Bremelanotide (PT-141) Nasal Spray

Important Safety Information — Bremelanotide (PT-141) Nasal Spray

Regulatory status

Not FDA-approved for any use. No nasal form of bremelanotide is FDA-approved. The only FDA-approved bremelanotide product, VYLEESI®, is an injection under the skin approved only for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD); its label says it is not indicated for postmenopausal women or men and is not indicated to enhance sexual performance. Compounded bremelanotide nasal spray is not that product, and the FDA has not reviewed it. A licensed provider reviews your health history, heart health, blood pressure and current medicines, explains what is and is not known, and decides whether it may be appropriate for you.

Off-label use. No bremelanotide product is FDA-approved for nasal use, for men or for postmenopausal women, so prescribing compounded bremelanotide nasal spray is outside any FDA-approved use and is decided by your provider.

Do not use if

• You have high blood pressure that is not controlled (a contraindication in the FDA label for the approved bremelanotide product)
• You have known cardiovascular (heart or blood vessel) disease (also a contraindication in that label)
• You are allergic to bremelanotide or any ingredient in the compounded preparation

Before starting, tell your provider if

• High blood pressure, heart problems or other cardiovascular risk factors
• Kidney or liver problems
• Darker skin, or any prior changes in skin pigmentation, because focal hyperpigmentation is more likely
• Oral naltrexone taken for alcohol or opioid dependence, and any oral medicine that needs a quick onset or a threshold level to work, such as antibiotics or pain relievers like indomethacin
• Every prescription and over-the-counter medicine, vitamin and herbal supplement
• Pregnancy, plans to become pregnant, the birth control you use, or breastfeeding

Serious side effects — get medical help right away

• Blood pressure increases. Its developer reported blood pressure increases in some people who used nasal bremelanotide, and blood levels after nasal use varied widely from person to person. In the FDA label for the approved injection, each dose temporarily raises blood pressure and lowers heart rate, usually resolving within about twelve hours. If you think you are having a medical emergency, call 911.
• Focal hyperpigmentation (skin darkening). In the FDA label for the approved bremelanotide product, darkening of the face, gums or breasts can occur, more often with darker skin and with frequent use, and may not fully resolve after stopping. Tell your provider about any skin changes.
• Nausea and vomiting. Nausea and vomiting were reported with nasal bremelanotide. In the FDA label for the approved injection, nausea was the most common side effect, sometimes severe, and pre-treatment with ondansetron was not found effective and is not recommended. Tell your provider about nausea that is severe or does not go away.
• Slowed absorption of oral medicines, including naltrexone. In the FDA label for the approved bremelanotide product, it may slow stomach emptying and lower the absorption of medicines taken by mouth. The label says to avoid it with oral naltrexone for alcohol or opioid dependence, because treatment failure can have severe consequences.

Common side effects

Common side effects: its developer reported nausea and vomiting with nasal bremelanotide. In the FDA label for the approved injection, the most common were nausea, flushing, injection site reactions, headache and vomiting. Side effects specific to nasal use have not been established through FDA review. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

In the FDA label for the approved bremelanotide product, animal studies suggest a potential for harm to an unborn baby, and the few pregnancies in clinical trials are not enough to know the risk in people. The label advises effective contraception during use and stopping if pregnancy is suspected. It is not known whether bremelanotide passes into breast milk. Tell your provider if you are pregnant, could become pregnant or are breastfeeding.

VYLEESI® is a registered trademark of Cosette Pharmaceuticals, Inc. Forever Health Rx is not affiliated with Cosette Pharmaceuticals, Inc.

Prescription only. PT-141 Nasal Spray is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.