Your safety is our first priority. Learn more about key medication details, possible side PT-141 (Bremelanotide)
Your safety is our first priority. Learn more about key medication details, possible side effects, warnings, and other important information about PT-141 below.
Prescribing Information
PT-141, also known as bremelanotide, is a prescription medication that acts on melanocortin receptors involved in sexual desire and arousal.
The FDA-approved bremelanotide injection is indicated for certain premenopausal women with acquired, generalized hypoactive sexual desire disorder, or HSDD. It is not FDA-approved for men or postmenopausal women.
A provider may prescribe bremelanotide off-label for eligible men or postmenopausal women based on the patient’s symptoms, medical history, treatment goals, and clinical judgment.
Tummala Health may offer the following compounded formulations:
- Nasal spray: 5 mg/mL
- Subcutaneous injection: 10 mg/mL
The compounded nasal spray and multidose injection are not FDA-approved drug products. Their dosing, effectiveness, absorption, and safety may differ from the FDA-approved bremelanotide autoinjector.
Boxed Warning
Bremelanotide does not have an FDA boxed warning.
Its most important risks include temporary increases in blood pressure, decreases in heart rate, nausea, vomiting, flushing, headache, focal skin darkening or hyperpigmentation, and possible medication interactions.
Common and Possible Side Effects
Common or possible side effects may include:
- Nausea
- Flushing or hot flashes
- Headache
- Vomiting
- Dizziness
- Fatigue
- Nasal congestion
- Temporary increases in blood pressure
- Temporary decreases in heart rate
- Injection-site pain, redness, itching, bruising, or swelling
- Darkening of the skin, gums, face, or breasts
- Nasal discomfort or irritation with the compounded nasal formulation
Nausea, flushing, injection-site reactions, headache, and vomiting are among the most commonly reported reactions with FDA-approved injectable bremelanotide.
Important Safety Information
Do not use PT-141 if you have uncontrolled high blood pressure or known cardiovascular disease.
Tell your provider if you have:
- High blood pressure
- Heart or cardiovascular disease
- A history of heart attack or stroke
- A high risk of cardiovascular disease
- Kidney or liver problems
- Persistent nausea or vomiting
- Previous unusual skin or gum darkening
- Any condition that may make sexual activity medically inadvisable
PT-141 may temporarily increase blood pressure and reduce heart rate after a dose. With FDA-approved injectable bremelanotide, these effects generally peak within several hours and usually return to baseline within approximately 12 hours.
Tell your provider about every medication you take. Bremelanotide may slow stomach emptying and affect the absorption of certain oral medications. Avoid use with oral naltrexone products used for alcohol or opioid dependence unless specifically cleared by your provider because bremelanotide may reduce naltrexone exposure.
Women who are pregnant, may be pregnant, or are trying to become pregnant should tell their provider. Discontinue treatment and contact your provider if pregnancy is suspected. Women who may become pregnant should use effective contraception during treatment.
Do not use both the nasal and injectable formulations together unless your provider specifically instructs you to do so.
Do not use more than one dose within 24 hours. Follow the maximum monthly frequency stated on your prescription label. The FDA-approved bremelanotide product recommends no more than eight doses per month; your provider must confirm the appropriate limit for your compounded formulation.
Seek immediate medical attention for chest pain, fainting, severe or persistent headache, difficulty breathing, signs of an allergic reaction, or symptoms suggesting a serious blood-pressure or cardiovascular reaction.
Men using PT-141 should ask their provider what to do if an erection becomes prolonged or painful. Your clinical team should confirm whether an explicit four-hour priapism warning should be included in its male-treatment protocol because the FDA-approved labeling was developed for women and does not address use in men.
Reporting Side Effects
To report a suspected adverse reaction or medication-quality problem, contact your healthcare provider and submit a report through FDA MedWatch or call 1-800-FDA-1088.
