Important PT-141 (Bremelanotide) Safety Information
Important Safety Information for PT-141 (Bremelanotide)
Please carefully read the following safety information regarding your prescription of PT-141:
Risks and Precautions:
- PT-141 may cause temporary increases in blood pressure and decreases in heart rate after administration.
- Use caution if you have uncontrolled high blood pressure, cardiovascular disease, kidney disease, or liver disease.
- PT-141 may cause nausea, vomiting, headache, and flushing particularly with frequent use.
- Notify your healthcare provider immediately if you experience severe chest pain, significant increases in blood pressure, severe allergic reactions, difficulty breathing, or persistent vomiting.
Usage Guidelines:
- Take your medications exactly as prescribed by your healthcare provider.
- Do not share your medications with others.
- Do not exceed the prescribed dose or frequency of administration.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.
Off Label:
- Compound medications, while regulated, are not FDA approved, and their use is considered off-label.
For any questions or concerns regarding your medication, contact our support team immediately.
This statement does not replace individual medical advice provided by your healthcare professional. Always follow the specific instructions given by your provider.
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Important PT-141 Safety Information
Warning: Risk of Increased Blood Pressure- PT-141 may cause transient increases in blood pressure and reductions in heart rate. Patients with uncontrolled hypertension or significant cardiovascular disease should use caution.
Note regarding compounded medications – Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your Ivim Health provider may recommend certain doses of compounded medications based on your medical evaluation.
What is the FDA-approved use of PT-141?
Bremelanotide (Vyleesi®) is FDA-approved for the treatment of acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.
Limitations of Use
- PT-141 is not approved for the treatment of sexual dysfunction secondary to medical, psychiatric, or relationship issues.
- PT-141 is not approved to enhance sexual performance.
- Use in men and postmenopausal women is considered off-label.
- PT-141 in a formulation other than injection is not FDA approved.
Who should not use PT-141?
You should not use PT-141 if you:
- Have uncontrolled hypertension.
- Have known cardiovascular disease where blood pressure increases may present a risk.
- Have a known allergy to bremelanotide or any ingredient in the formulation.
- Are pregnant unless specifically directed by your healthcare provider.
- Have severe liver impairment or severe kidney disease without provider approval.
How should PT-141 be administered?
PT-141 is available in an oral troche. You should place the troche in your mouth under your tongue and allow it to dissolve completely. This should be done 30-45 minutes prior to anticipated sexual activity as needed. You should not chew it or swallow it whole.
What should I tell my IVIM provider before starting PT-141?
PT-141 may interact with certain medications and may affect the absorption of oral medications by slowing gastric emptying.
Tell your provider about all medications you take, including:
- Prescription medications
- Over-the-counter medications
- Vitamins
- Herbal supplements
- Weight-loss medications
- Erectile dysfunction medications
- Blood pressure medications
It is especially important to discuss:
- Hypertension
- Cardiovascular disease
- Kidney disease
- Liver disease
- Pregnancy or plans to become pregnant
- Prior allergic reactions to injectable medications
Medications to watch out for (interactions): Please note, this is not an exhaustive list, and interactions are not limited to the following medications.
- Nitroglycerin
- Isosorbide
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
Uncontrolled hypertension
Cardiovascular disease
Kidney disease
Liver disease
What are the most serious side effects that I or a caregiver should monitor for?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Significant Increase in Blood Pressure- PT-141 may temporarily elevate blood pressure and reduce heart rate. Seek immediate medical attention if you experience:
- Severe chest pain
- Severe headache
- Vision changes
- Shortness of breath
- Neurological symptoms
Severe Allergic Reactions- Stop using PT-141 and seek emergency medical care if you experience:
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing
- Difficulty swallowing
- Severe rash
- Fainting or dizziness
Severe Nausea or Vomiting-Persistent nausea and vomiting may lead to dehydration and may require medical evaluation.
What are the most common side effects of PT-141?
- Nausea
- Vomiting
- Headache
- Flushing
- Fatigue
- Nasal congestion
- Dizziness
- Increased blood pressure
This information is not comprehensive. Please see full prescribing information for PT-141 for complete safety information.
Disclaimer:
PT-141 may be available as a compounded medication through licensed compounding pharmacies. Compounded medications are not FDA-approved but are prepared by pharmacists to meet individual patient needs based on a valid prescription. The safety, efficacy, and quality of compounded PT-141 may vary depending on the pharmacy and formulation.
Always consult with a licensed healthcare provider before starting PT-141 therapy.
This document may include information about the use of medications, supplements, or therapies that are not approved by the U.S. Food and Drug Administration (FDA) for the specific indication discussed. Such off-label use is based on clinical judgment, emerging research, or standard-of-care practices and is intended to support safe, evidence-informed decision-making.
