Important Safety Information — Compounded Bremelanotide

What is this?

This Important Safety Information summarizes key warnings, precautions, contraindications, and possible side effects for compounded bremelanotide, a prescription medication used in certain patients when a licensed healthcare provider determines that bremelanotide therapy is medically appropriate.

This page does not include all possible information about compounded bremelanotide. Always follow your prescription label, pharmacy instructions, and the instructions provided by your ATHS healthcare provider.

Compounded bremelanotide is not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are dispensed. Compounded medications may be prescribed when a licensed healthcare provider determines that a compounded preparation is medically appropriate for a specific patient.

Bremelanotide is a melanocortin receptor agonist. The mechanism by which bremelanotide affects sexual desire is not fully understood.

Bremelanotide is associated with important safety considerations, including temporary increases in blood pressure, decreases in heart rate, nausea, focal skin darkening, and potential interactions with certain oral medications. Your provider will determine whether bremelanotide therapy is medically appropriate based on your symptoms, medical history, cardiovascular risk factors, blood pressure, medication use, and treatment goals.

Who should not use compounded bremelanotide?

Do not use compounded bremelanotide if you have uncontrolled high blood pressure or known cardiovascular disease.

Compounded bremelanotide may not be appropriate for patients at high risk for cardiovascular disease. Tell your provider if you have high blood pressure, heart disease, chest pain, history of heart attack, history of stroke, abnormal heart rhythm, circulation problems, or any other cardiovascular condition.

Blood pressure and heart rate

Compounded bremelanotide may temporarily increase blood pressure and decrease heart rate after each dose. These changes usually resolve within about 12 hours, but they may be more concerning in patients with cardiovascular risk factors.

Your provider may review your blood pressure, cardiovascular history, medication list, and overall risk factors before and during treatment. Do not use more than one dose within 24 hours. Using doses too close together may increase the risk of more pronounced blood pressure effects.

Using compounded bremelanotide more frequently than directed may increase the risk of blood pressure effects and focal skin darkening. Do not use more often than instructed by your prescription label, pharmacy instructions, or ATHS healthcare provider.

Skin darkening

Compounded bremelanotide may cause focal hyperpigmentation, which means darkening of the skin in certain areas. Skin darkening has been reported on the face, gums, and breasts.

The risk of skin darkening may be higher in patients with darker skin and may increase with more frequent use. Skin darkening may not fully resolve after stopping bremelanotide. Contact your provider if you notice new or worsening darkening of the skin, gums, or breasts.

Nausea

Nausea is one of the most commonly reported side effects associated with bremelanotide. Nausea may occur more often with the first dose and may last for several hours, although it may last longer in some patients.

Some patients may require medication to manage nausea. Contact your provider if nausea is persistent, severe, worsening, or difficult to tolerate.

Possible side effects

Possible side effects associated with bremelanotide include nausea, flushing, injection site reactions, headache, vomiting, cough, fatigue, hot flashes, tingling or abnormal skin sensations, dizziness, and nasal congestion.

Other reported side effects include abdominal pain, diarrhea, muscle pain, joint pain, pain in the extremities, restless legs, runny nose, increased creatine phosphokinase, increased blood pressure, and focal skin hyperpigmentation.

Injection site reactions

Injection site reactions may include pain, redness, itching, bruising, bleeding, swelling, hematoma, numbness, tingling, or irritation at the injection site. Contact your provider if an injection site reaction is severe, worsening, painful, warm to the touch, draining fluid, or does not improve.

Drug interactions

Compounded bremelanotide may slow stomach emptying and may affect how certain oral medications are absorbed. Tell your provider about all medications you take, including prescription medications, over-the-counter medications, vitamins, and supplements.

Use caution with oral medications that need to work quickly or depend on precise absorption, including certain antibiotics and medications used for pain relief. Contact your provider if you notice delayed or reduced effects from an oral medication while using compounded bremelanotide.

Do not use compounded bremelanotide with oral naltrexone products used to treat alcohol or opioid addiction. Bremelanotide may significantly reduce naltrexone exposure and may reduce treatment effectiveness.

Pregnancy

Compounded bremelanotide is not recommended during pregnancy. Patients who can become pregnant should use effective contraception while using bremelanotide and should stop using it if pregnancy is suspected.

Available human pregnancy data are limited. Animal data described in bremelanotide prescribing information suggest potential fetal harm. Tell your provider right away if you are pregnant, planning to become pregnant, or think you may be pregnant.

Breastfeeding

It is not known whether bremelanotide passes into human milk, affects a breastfed child, or affects milk production. Tell your provider if you are breastfeeding or planning to breastfeed.

Kidney or liver impairment

Patients with severe kidney impairment or severe liver impairment may have an increased risk of adverse reactions, including nausea and vomiting. Tell your provider if you have kidney disease, liver disease, abnormal kidney function, or abnormal liver function.

Use in pediatric or geriatric patients

The safety and effectiveness of bremelanotide have not been established in pediatric patients or geriatric patients.

Missed Dose

If you miss a dose, follow the instructions on your prescription label or contact your healthcare provider or pharmacy.

Do not use extra compounded bremelanotide to make up for a missed dose. Do not change your dosing schedule or frequency of use without medical direction.

Overdose

Using too much compounded bremelanotide, or using it more often than directed, may increase the risk of nausea, focal skin darkening, and more pronounced blood pressure increases.

In case of overdose or accidental exposure, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

Storage

Follow the storage instructions provided by your pharmacy.

Unless your prescription label or pharmacy instructions state otherwise, store medication at controlled room temperature, generally 20°C to 25°C / 68°F to 77°F, away from excessive heat, moisture, and direct light.

In general:

• Store medication at the temperature listed on the prescription label.
• Keep away from excessive heat, moisture, and direct light.
• Keep out of reach of children and pets.
• Do not use medication that appears contaminated, discolored, damaged, crystallized, cloudy, leaking, or otherwise unusual.
• If using injectable medication, use only as instructed and dispose of needles and syringes in an appropriate sharps container.

Medication Disposal

Do not flush unused medication down the toilet or pour it into a sink or drain unless specifically instructed.

Preferred disposal method:

• Use a DEA-authorized drug take-back location when available.
• If no take-back option is available, follow local disposal guidance or ask your pharmacist for instructions.

For injectable supplies, place needles and syringes in an approved sharps container. Do not place loose needles directly into household trash.

When to contact your provider

Contact your provider if you experience persistent or severe nausea, vomiting, severe headache, dizziness, faintness, new or worsening skin darkening, symptoms of elevated blood pressure, delayed effects from oral medications, concerning injection site reactions, yellowing of the skin or eyes, dark urine, severe abdominal pain, or any side effect that feels unusual or concerning.

Seek emergency medical care

Seek emergency medical care if you experience chest pain, sudden shortness of breath, symptoms of stroke, fainting, severe allergic reaction, severe or sudden headache, severe dizziness, or any sudden or severe symptoms after using compounded bremelanotide.

Reporting Side Effects

Tell your healthcare provider if you experience side effects or symptoms that concern you.

You may report suspected adverse reactions or product quality concerns to the FDA through MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.

Telemedicine Disclosure

This prescription may be issued through telemedicine after review by a licensed healthcare provider. If you experience concerning symptoms, contact your ATHS provider or seek emergency medical care.

Withholding or providing inaccurate information about your symptoms, medical history, medications, substance use, allergies, prior reactions, lab results, blood pressure, cardiovascular history, kidney or liver function, pregnancy status, breastfeeding status, or other relevant health information may result in serious harm.

Disclaimer

This information is not comprehensive and does not include all possible risks, side effects, interactions, warnings, or precautions associated with compounded bremelanotide. This page does not provide medical advice, diagnosis, or treatment.

Compounded bremelanotide is prescribed only when a licensed healthcare provider determines that it is medically appropriate. Compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or quality before dispensing.

For questions about your medication, prescription, dosing, side effects, or treatment plan, contact your healthcare provider or pharmacist.