VYLEESI is an injectable drug that contains bremelanotide in the form of bremelanotide acetate, which is a melanocortin receptor agonist. It is provided as a sterile solution in a pre-filled autoinjector, containing 1.75 mg of bremelanotide in 0.3 mL for subcutaneous administration. Inactive ingredients in the formulation include glycerin and sterile water for injection.
How should I use this medication?
This medication is for injection under the skin. You will be taught how to prepare and give this medication. Use exactly as directed. Do not take your medication more often than directed. It is important that you put your used autoinjectors in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply. This medication is not for regular use.
Where should I keep my medication?
Keep out of the reach of children and pets. Store unopened autoinjectors at or below 25 degrees C (77 degrees F). Do not freeze. Protect from light. Throw away any unused medication after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
What side effects may I notice from receiving this medication?
Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in skin color -Increase in blood pressure -Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Fatigue -Flushing -Headache -Nausea -Pain, redness, irritation, or bruising at the injection site
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What should I tell my care team before I take this medication?
They need to know if you have any of these conditions: -Heart disease -High blood pressure -An unusual or allergic reaction to bremelanotide, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding
What may interact with this medication?
-Naltrexone products for substance use disorder
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medication?
Visit your care team for regular checks on your progress. Tell your care team if your symptoms have not improved after you have taken this medication for 8 weeks. Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.
Source: This information is sourced from Elsevier Inc.
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