Dr. Medicine

The Beauty Benefits of Natural Oils--

Why Try Natural Oils?
1/10
They are touted as alternatives to condition hair, moisturize skin, fight acne, and strengthen nails. Take a stroll down the beauty aisle of your drugstore and you’ll find them in many products. Do they work? You might need to experiment. Everyone’s skin is different, and it comes down to trial and error.

Marula
2/10
Made from the fruit of the marula tree, which is native to South Africa, this oil is rich and hydrating. It’s full of fatty acids, which dermatologists say soothe dry skin. It absorbs quickly and won’t leave you shiny or greasy.

Tea Tree
3/10
Red, inflamed breakouts happen when bacteria gets trapped inside your pores. Research shows that tea tree oil helps zap that bacteria. In one trial, it beat a placebo gel (which has no active ingredients) at treating acne and calming inflammation. Another study found that it was as effective as benzoyl peroxide, a common ingredient in over-the-counter zit remedies.

Argan
4/10
Sometimes called “liquid gold,” argan oil is rich in antioxidants called polyphenols, which can fight the effects of aging. Dermatologists also say its omega-3 fatty acids boost collagen growth and plump up your skin. It doesn’t matter if you have a dry, oily, or normal skin type.



It also conditions hair, but doesn’t weight it down or make it feel greasy. You can still use your other hair care products, too.

Chamomile and Peppermint
5/10
You probably think of chamomile as a relaxing tea, but the oil from this daisy-like plant can also calm your skin. Skin specialists call it an anti-inflammatory and an antiseptic, which cuts down on redness, irritation, and the chance of infection. Peppermint oil has the same soothing properties.

Coconut
6/10
Dry, cracked skin is more likely to get infected, irritated, and have allergic reactions. Coconut oil protects and moisturizes it, and soothes the scaly, rough patches that go along with common conditions like eczema, too.

Rosehip and Carrot
7/10
You’ll find vitamin A in lots of skin care products. It’s a “retinoid,” a chemical that helps replace old skin cells with new ones and make collagen, which can ease color changes from scarring and stretch marks. Two oils that are particularly rich in vitamin A: rosehip seed and carrot. Some dermatologists say they’re also good as acne and anti-aging treatments. You would use only a tiny dab at nighttime.

Rosemary and Castor
8/10
Want to plump up your ponytail? Does your scalp show more than it used to? Rosemary oil may help you get a thicker, shinier mane. In one study, 6 months of treatment worked as well as 2% minoxidil against androgenetic alopecia, a common form of hair loss in men and women. And it was less likely to cause an itchy scalp.



Castor oil is another home remedy said to thicken brows and lashes. Before you try it, ask your doctor if it’s safe, since it would go near your eyes. The jury’s still out as to whether it really works.

Olive and Avocado
9/10
Got thin or brittle nails? For a simple, all-natural solution, dab a little olive or avocado oil on them before bed. The oils will soak in overnight and nourish with good-for-you fatty acids. You can use other types of oil for this, too.

Sesame
10/10
Could you replace your mouthwash with oil? It’s trendy, but oil pulling, or rinsing out your mouth with oil, is a generations-old remedy for healthy teeth and gums. Research shows it might help. Recent international studies found that swishing with sesame oil (coconut and sunflower work, too) can cut plaque and gingivitis. It may also wash away the microorganisms that cause bad breath.

Courtesy--
Medically Reviewed by Zilpah Sheikh, MD
Written by Jennifer Rainey Marquez

بِسْمِ ٱللَّٰهِ ٱلرَّحْمَٰنِ ٱلرَّحِيمِ
বিসমিল্লাহির রাহমানির রাহীম।
FreePalestine 🇵🇸 #

16 Tips to Lower Your Cholesterol:

Simple Steps Add Up
1/17
Has your doctor said you have high cholesterol? Then you know you need to change your diet and lifestyle to lower cholesterol and your chance of getting heart disease. Even if you get a prescription for a cholesterol drug to help, you'll still need to change your diet and become more active for heart health. Start with these steps.

1. Know Good and Bad
2/17
Your body needs a small amount of cholesterol. But many people have too much, especially the “bad” kind, or LDL cholesterol. That can happen if you eat too much saturated fat, found mainly in foods from animals. If your LDL level is too high, plaque can build up in your heart's arteries and lead to heart disease. The “good” cholesterol, HDL, helps clear LDL from your blood.

2. Use Your Hands
3/17
It’s easy to eat too much, especially when you eat out and the portions are huge. That can lead to weight gain and higher cholesterol. What’s a true portion? There’s a “handy” way to tell. One serving of meat or fish is about what fits in your palm. One serving of fresh fruit is about the size of your fist. And a snack of nuts or serving of cooked vegetables, rice, or pasta should fit in your cupped hand.

3. Think Delicious and Nutritious
4/17
Load your plate with fruits and vegetables -- aim for five to nine servings each day -- to bring down your LDL level. Antioxidants in these foods may provide the benefit, along with fiber. And you may eat less fatty food if you fill up on produce. Bonus: You'll also help lower blood pressure and keep your weight in check.

4. Boost Your Omega-3s
5/17
You can eat fish twice a week. It’s a great source of protein and omega-3s, which are a type of fat your body needs. Omega-3s help lower levels of triglycerides, a type of fat in the blood. They may also cut down on cholesterol, slowing the growth of plaque in arteries. Go for fatty fish, such as salmon, tuna, trout, and sardines. Grill, roast, bake, or broil, but don’t fry them.

5. Start Your Day With Whole Grains
6/17
A bowl of oatmeal is a smart choice. It fills you up, making it easier not to overeat at lunch. The fiber also curbs LDL cholesterol. Whole grains aren’t just for breakfast. You’ve got plenty of options to try later in the day, such as brown or wild rice, popcorn, and barley.

6. Go Nuts
7/17
Need a snack? A handful of almonds, pecans, pistachios, walnuts, or other nuts is a tasty treat. They are high in monounsaturated fat, which lowers LDL "bad" cholesterol but leaves HDL "good" cholesterol alone. Studies show that people who eat about an ounce of nuts a day are less likely to get heart disease. Keep the portion small, so you limit fat and calories. And avoid those covered in sugar, chocolate, or a lot of salt.

6. Go Nuts
7/17
Need a snack? A handful of almonds, pecans, pistachios, walnuts, or other nuts is a tasty treat. They are high in monounsaturated fat, which lowers LDL "bad" cholesterol but leaves HDL "good" cholesterol alone. Studies show that people who eat about an ounce of nuts a day are less likely to get heart disease. Keep the portion small, so you limit fat and calories. And avoid those covered in sugar, chocolate, or a lot of salt.
7. Make It Unsaturated
8/17
You need some fat in your diet, but probably less than you think. Plus, the type of fat matters. Unsaturated fats -- like those found in canola, olive, and safflower oils -- lower LDL "bad" cholesterol levels and may help raise HDL "good" cholesterol. Saturated fats -- like those found in meat, full-fat dairy, butter, and palm oil -- raise LDL cholesterol. Remember, good fats have just as many calories, so use just a bit.

8. Pick the Best Carbs
9/17
Beans and whole grains such as brown rice, quinoa, and whole wheat have more fiber and don’t spike your blood sugar. They will lower cholesterol and make you feel full longer. Other carbs, like those found in white bread, white potatoes, white rice, and pastries, boost blood sugar levels more quickly so you feel hungry sooner, which can lead you to overeat.

9. Go for 30
10/17
Just half an hour of physical activity 5 days a week can lower your bad and raise your good cholesterol levels. More exercise is even better. Being active also helps you reach and keep a healthy weight, which cuts your chance of developing clogged arteries. You don't have to exercise for 30 minutes straight. You can break it up into 10-minute sessions. Or go for 20 minutes of harder exercise, like running, three times a week.

10. Walk It Off
11/17
It's simple, convenient, and all you need is a good pair of shoes. Aerobic exercise ("cardio") such as brisk walking lowers the chance of stroke and heart disease, helps you lose weight, keeps bones strong, and is great for your mood and stress management. If you're not active now, start with a 10-minute walk and build up from there.

11. Go Beyond the Gym
12/17
You can be active anywhere. Garden, play with your kids, hike, dance, walk your dog -- if you’re moving, it’s good! Even housework goes on the list if it gets your heart rate up. Do as much as possible, as often as you can, wherever your day takes you.

12. Be Smart When You Eat Out
13/17
Restaurant food can be loaded with saturated fat, calories, and sodium. Even “healthy” choices may come in supersize portions. To stay on track:

Choose broiled, baked, steamed, and grilled foods -- not fried.
Get sauces on the side.
Ask for half of your meal to be boxed up before you get it.

13. Check the Label
14/17
What’s the serving size? The nutrition info may look good, but does the package contain two servings instead of one?

If it says "whole grain," read the ingredients. Whole wheat or whole grain should be the first one.

Note the saturated fat, sodium, calories, and cholesterol. Are they OK for your daily plan? If not, what will you choose to change?

14. Stay Chill
15/17
Over time, out-of-control stress becomes a problem. It raises your blood pressure, and for some people, it might mean higher cholesterol levels. Make it a priority to relax. It can be as simple as taking some slow, deep breaths. You can also meditate, pray, socialize with people you enjoy, and exercise. And if some of the things that stress you out are things you can change, go for it!

15. Check Your Weight
16/17
Extra pounds make you more likely to get high cholesterol, high blood pressure, and type 2 diabetes. These all affect the lining of your arteries, making them more likely to collect plaque from cholesterol. Losing weight, especially belly fat, raises your good and lowers your bad cholesterol.

16. Keep Tabs
17/17
Celebrate your progress! Remember that you’re in charge of your health and that you can turn your cholesterol around. See your doctor regularly so you know how it’s going. Working together, you'll keep your heart going strong.

Always end the day with a positive thought. No matter how hard things were, tomorrow is a fresh opportunity to make it better.
In Sha Allah.😀

Safe Medication Use During Breastfeeding Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Sep 30, 2022.

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13 Reasons Why Sitting Too Much Is Bad for Your Health

Why Sitting Too Much Is Bad for Your Health Sit all day at the office? You might want to rethink that. Long hours in the chair are bad for your health. WebMD explains why it’s time to get up and stretch your legs.

How long does it take for Mounjaro to start working?

Mounjaro (generic name: tirzepatide) will start to lower your blood sugar levels right away but it can take 8 to 12 weeks to reach your target A1C goal. When compared to some other diabetes treatments, studies have shown that it can take 8 weeks to reach an A1C target of ≤7% and 12 weeks to reach an A1C ≤6.5% with Mounjaro. Significant weight loss can occur as early as 28-weeks.

A1C is a simple blood test that shows the average amount of sugar (glucose) in your blood over the past 2 to 3 months. Your healthcare provider will tell you what your what A1C goal should be.

How is Mounjaro used?
Mounjaro is given as a weekly injection under the skin (subcutaneous). It is used to help lower blood glucose (sugar) levels in type 2 diabetes, alongside diet and exercise, as prescribed by your doctor. In addition to blood sugar control, Mounjaro can help you lose weight, although it is not specifically approved for this use.

The recommended starting dosage is 2.5 mg subcutaneously once weekly, increasing to 5 mg once weekly after 4 weeks. The maximum dosage is 15 mg subcutaneously once weekly. Your doctor will slowly increase your dose to help prevent sides and monitor how well it's working.

Mounjaro is available as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg subcutaneous injection in a single-dose auto-injector pen. You can learn to give this injection at home.


For more information tap the link in our bio.

One Drug Clear Winner in Treating Acne: Review - Drugs.com MedNews MONDAY, July 31, 2023 Yes, suggests a new review of more than 200 studies. When researchers compared acne treatments, a clear winner emerged: oral isotretinoin, best known as Accutane.

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FDA Approves Xdemvy for Demodex Blepharitis - Drugs.com MedNews Xdemvy was generally safe and well tolerated. The most common ocular adverse reactions included instillation site stinging and burning (reported in 10 percent of patients), as well as chalazion/hordeolum (stye) and punctate keratitis (less than 2 percent of patients).

Pain Management: Types of Pain and Treatment Options Pain is one of the most misunderstood and ineffectively treated symptoms. What are the different types of pain and what treatments work best for each type?

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Nasal Swab for Bacteria Might Slash Antibiotic Prescribing in Kids - Drugs.com MedNews "When a child comes in with a sore throat, we test for strep [a bacteria]. If the test is negative, we do not prescribe antibiotics," said lead researcher Dr. Nader Shaikh, a professor of pediatrics and clinical and translational science at the University of Pittsburgh School of Medicine.

Top 10 Diabetes Treatments You May Have Missed Review important FDA prescription medicine approvals for type 2 diabetes.

FDA Approves Cyfendus---

FDA Approves Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use

GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of Cyfendus vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

“The approval of Cyfendus vaccine is symbolic of Emergent's longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

“Cyfendus vaccine is a component of the U.S. government’s preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact,” said Paul Williams, Emergent’s senior vice president, products business. “The approval of the Cyfendus vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the U.S. government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine.”

Cyfendus vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, which can be especially important in response to a large-scale public health emergency involving anthrax. In December 2018, Cyfendus vaccine was the subject of a pre-emergency use authorization package submitted to the FDA. The following year, the U.S. government began procuring this product for national preparedness efforts.

In addition to the Cyfendus vaccine, Emergent’s anthrax franchise includes the BioThrax® vaccine, which will continue to serve a critical purpose, as well as two treatments, Anthrasil® [Anthrax Immune Globulin Intravenous (human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.

The FDA approval of Cyfendus vaccine is based on data from a series of studies supported by the U.S. government and conducted by Emergent, including:

a pivotal Phase 3 clinical study that evaluated the lot consistency, immunogenicity, and safety of the vaccine following a two-dose schedule administered intramuscularly in healthy adults,
a Phase 2 study that evaluated non-interference between the vaccine and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease, and
non-clinical studies that assessed protective efficacy of the vaccine against lethal challenge with anthrax spores and helped identify neutralizing antibody levels associated with protection against disease.
The Biologics License Application submission and attainment of product licensure were completed under contract number HHSO100201600030C for the advanced development and delivery of Cyfendus vaccine, funded by BARDA, within the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services. Early-stage development funding was also provided by NIAID, part of the National Institutes of Health, and DARPA of the U.S. Department of Defense.

About Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted)

Indication

Cyfendus (Anthrax Vaccine Absorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of anthrax disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when given with recommended antibacterial drugs.

The efficacy of Cyfendus vaccine for post-exposure prophylaxis (PEP) is based solely on studies in animal models of inhalational anthrax.

Important Safety Information

Contraindication: Do not take Cyfendus vaccine if you are allergic to Cyfendus vaccine, BioThrax® (Anthrax Vaccine Adsorbed) or any ingredient of the vaccine.

Allergic reactions: Appropriate medical treatment and supervision must be available after receiving Cyfendus vaccine to manage possible serious allergic reactions. Get medical help right away if you have any symptoms of a serious allergic reaction.

Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to Cyfendus vaccine.

Pregnancy: Cyfendus vaccine can cause fetal harm when administered to a pregnant individual. Before getting Cyfendus vaccine, tell your healthcare provider if you may be pregnant, plan to get pregnant soon, or are nursing a baby.

Adverse reactions: The most common adverse reactions reported were tenderness, pain, warmth, itching, swelling, redness, bruising, arm motion limitations, muscle aches, tiredness, headache, and fever.

About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared, just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, Twitter, and Instagram.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the development, availability, and government procurement of CYFENDUS™ vaccine and the continued development of Emergent’s anthrax franchise, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.

Source: Emergent BioSolutions

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Gilenya: 7 things you should know --

1. How it works
Gilenya is a brand (trade) name for fingolimod which may be used to treat multiple sclerosis.
Gilenya (fingolimod) is thought to work by blocking the migration of lymphocytes (a type of immune cell) from the lymph nodes into the bloodstream. Gilenya (fingolimod) is derived from myriocin (ISP-1), a natural immunosuppressant, and metabolite of the fungus Isaria sinclairii. It was first made by Yosh*tomi Pharmaceuticals in 1992 from ISP-I through chemical modification.
Gilenya belongs to the class of medicines known as selective immunosuppressants.

2. Upsides
Gilenya is an immunosuppressant that may be used for the treatment of relapsing multiple sclerosis (MS) in adults, and children aged 10 years and older.
Gilenya reduces nerve inflammation and subsequent damage.
The dose of Gilenya is the same for adults and children over the age of 10 who weigh more than 40kg: 0.5 mg once daily. For those under 40kg, the dose should be reduced to 0.25mg once daily.
Gilenya is taken by mouth (orally) once a day.
May be taken with or without food.
No dosage adjustment is needed for people with mild-to-moderate liver disease.

3. Downsides
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

Abdominal pain, an increase in blood triglycerides, an increased risk of basal cell carcinoma (2%) and skin papilloma (3%), an increased risk of infections, such as the flu, sinusitis, bronchitis, herpes zoster, and tinea versicolor; back pain or other pain; blood disorders; blurred vision; bradycardia (a slow heart rate); cough; diarrhea; hair loss; headache; high blood pressure; liver enzyme elevations and liver injury; migraine; nausea; shortness of breath; weakness.
Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients with MS who received Gilenya. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that often leads to death or severe disability. Posterior reversible encephalopathy syndrome (PRES) and respiratory effects have also been reported.
Hair loss is an uncommon side effect of Gilenya. In clinical trials, 3% of people who had hair loss were taking Gilenya, compared with 2% of people taking a placebo.
Gilenya should not be given to people who have experienced a heart attack (myocardial infarction) in the last 6 months, or with various other cardiovascular conditions such as unstable angina, stroke, or severe heart failure; with a baseline QTc interval ≥ 500 msec; with cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs; with a previous allergic reaction to fingolimod or any of the excipients in Gilenya.
Obtain a CBC before initiating treatment with Gilenya. Gilenya causes a dose-dependent reduction in peripheral lymphocyte count to 20%–30% of baseline values via redistribution in secondary lymphoid organs. This means that peripheral blood lymphocyte counts cannot be utilized to evaluate lymphocyte levels in a patient treated with Gilenya. Within 6 months of starting Gilenya obtain serum transaminases (ALT and AST) and total bilirubin levels.

A full cardiac evaluation should be conducted before starting Gilenya in those with pre-existing conditions, such as ischemic heart disease, a history of myocardial infarction, or cerebrovascular disease. Conduct a full medication review for other medications that may also slow the heart rate and consider modifying treatment before initiating Gilenya.
Gilenya does not cure MS, it only decreases the frequency of relapses.
Gilenya will suppress the immune system and will reduce a person's ability to fight infection. This ability will be further compromised if the person is also taking other drugs that suppress the immune system, such as chemotherapy agents, immune-modulating therapies, or other immunosuppressants. This immune-suppressing effect will persist for up to two months after stopping Gilenya treatment. Review all other immune-suppressing medications before initiating Gilenya, and be aware of those with a long half-life whose effects may persist for weeks after discontinuation, such as natalizumab, teriflunomide, or mitoxantrone. Life-threatening and fatal infections have occurred in association with Gilenya.
Gilenya will also reduce the immune response to live vaccines, such as MMR and varicella vaccines. All vaccines should be up to date before Gilenya is even started. Test patients for antibodies to varicella zoster virus (VZV) before initiating Gilenya and vaccinate all antibody-negative patients with VZV vaccination before commencing treatment with Gilenya. All pediatric patients should complete all immunizations per current immunization guidelines before initiating Gilenya therapy, if possible.
Gilenya can increase the risk of macular edema. Perform an eye examination before starting treatment, again 3 to 4 months after starting treatment, and again at any time after a patient reports visual disturbances while on Gilenya therapy.
Gilenya can cause bradycardia, particularly on first dose initiation. The maximum decline in heart rate generally occurs within 6 hours of the first dose and recovers, although not to baseline levels, by 8 to 10 hours post dose. There is also a second period of heart rate decrease within 24 hours because of physiological diurnal variation. In trials, symptomatic bradycardia following the first dose was reported in 0.6% of patients receiving Gilenya 0.5 mg and in 0.1% of patients on a placebo. Most were asymptomatic, but some experienced hypotension, dizziness, fatigue, palpitations, and/or chest pain.
The first dose of Gilenya should be initiated in a setting that can appropriately manage people for symptomatic bradycardia (a slow heartbeat) for 6 hours (sometimes longer). Before the first dose and at the end of the observation period an ECG should be obtained in all patients. During the 6 hours, the patient's pulse and blood pressure should be taken every hour. Continue monitoring after the 6 hours if any of the following are present: a heart rate less than 45 bpm in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age; the heart rate taken 6 hours postdose is at the lowest value suggesting that the maximum pharmacodynamic effect on the heart may not have occurred; the ECG obtained 6 hours postdose shows new onset second degree or higher AV block. Continue monitoring until symptoms have resolved if no pharmacological treatment is required, or if treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose. Some patients may require continuous ECG monitoring overnight (see product information for details).
First-dose monitoring for bradycardia is required by all patients if Gilenya is stopped with an interruption of one day or more during the first two weeks or during weeks 3 and 4 of treatment, after treatment interruptions of more than 7 days. Thereafter, first-dose monitoring is required for interruptions of longer than 14 days.
Gilenya is expensive. Gilenya 0.5mg costs around $302 per capsule, or $9053 for a supply of 30 capsules. however, 96 to 99% of people with commercial or private health insurance or who are eligible for Medicare or Medicaid are covered for Gilenya. Co-pay assistance is also available through the GILENYA Medical Co-Pay Support Program. Most people pay nothing. The cost of pre-tests and first observations may also be covered.
Gilenya interacts with many medications, particularly those with immune-lowering effects or those that slow the heart.
In people with kidney disease, the blood levels of some Gilenya metabolites may be increased up to 13-fold. There has not been enough research to determine what effects this has.
Gilenya may cause harm to a developing baby and animal studies have reported developmental toxicity at doses less than the recommended human dose. All females of reproductive potential should use effective contraception to avoid pregnancy during and for 2 months after stopping Gilenya treatment.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects.

4. Bottom Line
Gilenya is an immunosuppressant that may be used to treat relapsing forms of MS in adults and children over the age of 10. It can increase your risk of infection and interact with multiple drugs, and there is a risk that your MS symptoms may worsen if you stop taking Gilenya. A headache, nausea, diarrhea, and abdominal pain are some of the most common side effects reported.

5. Tips
You can take Gilenya with or without food, but you should try and take it at the same time each day. If you miss a dose, take it as soon as you remember. If it is close to your next dose, miss that dose do not double up your dosage. If you miss a dose in your first two weeks of taking Gilenya, contact your doctor as they may need to monitor your heart rate again.
Gilenya can slow your heart rate, and this is more likely to happen with the very first dose of Gilenya, or if you miss a dose during the first two weeks of treatment, and then start taking Gilenya again.
While you are taking Gilenya you are at an increased risk of infections, because Gilenya lowers your immune response. Some vaccinations may need to be avoided during treatment with Gilenya and for two months after stopping it. Take care to avoid people who are unwell and protect yourself from injury. See your doctor immediately if you develop any signs of an infection which may include fever, pain, swelling, redness, or a discharge.
Although Gilenya is expensive, most people pay nothing because 96 to 99% of people with commercial or private health insurance or who are eligible for Medicare or Medicaid are covered for Gilenya. Co-pay assistance is also available through the GILENYA Medical Co-Pay Support Program. The cost of pre-tests and first observations may also be covered. For those experiencing financial hardship or with no prescription coverage, The Novartis Patient Assistance Foundation, Inc. (NPAF) is committed to providing access to Novartis medications for those most in need. Call the Gilenya Go Program at 1 800-445-3692.
Do not stop taking Gilenya without talking to your prescriber first. In 2018, the FDA issued a warning stating that there is a possibility for some people that their MS may worsen significantly on stopping Gilenya. This worsening is rare but could result in permanent disability. The increase in disability generally occurred within 12 weeks after stopping Gilenya but was reported up to 24 weeks after Gilenya's discontinuation. Reasons for stopping may include intolerable adverse drug reactions, planned or unplanned pregnancy, or because the medicine is not working.
Gilenya can increase your risk of macular edema and you should have an eye test before starting treatment with Gilenya, 3 to 4 months after starting treatment, and then regularly thereafter.
See your doctor if you experience any unusual or worrying side effects, such as abdominal pain, fainting, heart palpitations, a rash, nausea, vomiting, shortness of breath, fever, or vision problems. Gilenya can also increase your risk of developing progressive multifocal leukoencephalopathy (PML), a serious viral infection, and symptoms may include progressive weakness on one side of the body, limb clumsiness, vision disturbance, changes in thinking, memory, and orientation leading to confusion and personality changes. See your doctor immediately if any of these symptoms happen to you.
Gilenya is not safe to use during pregnancy and is not recommended during breastfeeding. If you are of child-bearing potential you may have to undertake a pregnancy test before starting Gilenya and use reliable contraception while taking it. If you inadvertently become pregnant during Gilenya treatment or within 2 months of stopping it, tell your doctor straight away.
Gilenya can increase your risk of developing skin cancer including basal cell carcinomas and melanomas. Protect your skin from sunlight and wear protective clothing and use sunscreen with a high sun protection factor. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole or sores that do not heal.
Gilenya capsules should be kept at room temperature 20ºC to 25ºC (68ºF-77ºF) and protected from moisture.

6. Response and effectiveness
The annualized relapse rate was significantly lower in patients treated with Gilenya than in patients who received a placebo an inactive treatment) in a study that enrolled over 1200 people with MS. After two years, 70% of people reported no relapse compared with 46% of those taking a placebo. The mean (median) number of new or newly enlarging T2 lesions over 24 months was 2.5 with Gilenya and 9.8 with placebo. Other studies have shown similar results.
Gilenya lasts in the blood for a long time, and lymphocyte counts take 1 to 2 months to return to baseline. After stopping therapy, a person’s immune system will remain compromised for up to two months after stopping Gilenya treatment, which means their risk of infection will remain increased.
Research has shown Gilenya decreases blood lymphocytes to approximately 60% of baseline within four to six hours of the first dose. With continued dosing, the lymphocyte count continued to decrease eventually reaching a low point (called the nadir count) of blood lymphocyte count that corresponded to 30% of baseline or 500 cells/mcL after two weeks.
Some studies have reported nadir counts of < 200 cells/mL in patients on at least one occasion.
Gilenya is known as a disease-modifying drug and it reduces the number of relapses of multiple sclerosis (MS) by about half (50%). Any relapses that do happen should be less severe. It takes approximately two weeks of dosing for Gilenya to reach its maximum effect, which is a lymphocyte count of 30% of baseline or around 500 cells/mcL.
There is a risk that your MS symptoms may worsen if you stop taking Gilenya. This effect is rare, with 35 known cases documented over 8 years. Recovery varied. 17 patients had partial recovery, 8 experienced permanent disability or no recovery, and 6 eventually returned to the level of disability they had before or during Gilenya treatment. Several patients who were able to walk without assistance before discontinuing Gilenya progressed to needing wheelchairs or becoming bedbound.
Dosages of Gilenya higher than 0.5mg once a day are associated with more side effects with little extra benefit.

7. Interactions
Medicines that interact with Gilenya may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Gilenya. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Gilenya interacts with over 500 medications; the majority of these interactions are considered major. Common medications that may interact with Gilenya include:

antibiotics such as azithromycin, ciprofloxacin, or norfloxacin
antineoplastics, such as capecitabine, or cyclophosphamide
antipsychotics, such as clozapine, aripiprazole, or haloperidol
astemizole
biologics, such as adalimumab, etanercept, golimumab, or infliximab
busulfan
corticosteroids (such as prednisone or dexamethasone)
heart medications, particularly those that also slow the heart rate, such as beta-blockers (eg, atenolol, sotalol), digoxin, amiodarone, or flecainide (may be associated with severe bradycardia or heart block)
herbals, such as black cohosh or brewer's yeast
HIV medications, such as atazanavir or zidovudine
hydroxychloroquine
immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
interferon
ketoconazole (may increase blood levels of Gilenya up to 1.7 fold. Monitor)
lithium
live vaccines and some other vaccines, such as BCG, cholera, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (Gilenya reduces the immune response to vaccination if vaccines are given within 2 months of a Gilenya dose)
methotrexate
oxytocin
probiotics, such as lactobacillus
promethazine
quinine
tamoxifen.
There is a risk Gilenya may exacerbate the QT-prolonging effects of some medications, such as citalopram, chlorpromazine, haloperidol, methadone, or erythromycin. Initiation of Gilenya treatment results in a decreased heart rate which may prolong the QT interval. Monitor all patients already on QT-prolonging drugs with a known risk of torsades de pointes overnight with continuous ECG in a medical facility when starting Gilenya.

Gilenya may have additive immune-suppressing effects when given with any other medications such as anticancer drugs, immune-modulating, or immunosuppressive therapies, which may increase a person's risk for infection. Take this into account when switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide, or mitoxantrone.

Strong enzyme inducers, such as carbamazepine, rifampicin, phenytoin, phenobarbital, and St. John’s wort, have been shown to decrease Gilenya blood concentrations by approximately 40%. The clinical impact of this decrease is unknown.

Note that this list is not all-inclusive and includes only common medications that may interact with Gilenya. You should refer to the prescribing information for Gilenya for a complete list of interactions.

References
Gilenya (fingolimod hydrochloride) [Package insert]. Updated 01/2023. Novartis Pharmaceuticals Corporation https://www.drugs.com/pro/gilenya.html
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Gilenya only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Gilenya: Package Insert - Drugs.com Gilenya package insert / prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions and pharmacology.