Important Safety Information — Pregnyl for Men

What is Pregnyl?

Pregnyl is a prescription medication containing chorionic gonadotropin, also known as hCG. In males, hCG acts similarly to luteinizing hormone and can stimulate Leydig cells in the testes to produce androgens. Pregnyl may be used in selected male patients when a healthcare provider determines that treatment is medically appropriate.

This information does not include all possible warnings, precautions, side effects, or risks. Always follow your prescription label, pharmacy instructions, and the instructions provided by your ATHS healthcare provider.

Who should not use Pregnyl?

Do not use Pregnyl if you have had a prior hypersensitivity or allergic reaction to human gonadotropins, including hCG, or to any ingredient in Pregnyl.

Do not use Pregnyl if you have, or are suspected of having, a tumor of the hypothalamus, pituitary gland, breast, or prostate unless your healthcare provider has specifically evaluated your condition and determined that treatment is appropriate.

Tell your healthcare provider if you have any uncontrolled endocrine disorder, including a thyroid, adrenal, or pituitary disorder, before starting treatment.

Pregnyl should not be used for weight loss, fat loss, appetite control, or body-fat redistribution. hCG has not been shown to increase weight loss beyond caloric restriction, decrease hunger, or create a more attractive or “normal” distribution of body fat.

Important Warnings and Precautions

Serious allergic reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported with urinary-derived hCG products. Stop using Pregnyl and seek medical care if you develop symptoms of a serious allergic reaction.

Fluid retention: hCG may stimulate androgen production, which can cause fluid retention. Use Pregnyl with caution if you have heart disease, kidney disease, high blood pressure, epilepsy, migraines, or asthma.

Hormone-related effects: Because Pregnyl may increase androgen production, your healthcare provider may monitor your symptoms and lab results during treatment. Report breast tenderness, breast enlargement, swelling, mood changes, or other unexpected symptoms.

Prostate and breast conditions: Tell your healthcare provider if you have a history of prostate cancer, elevated PSA, prostate enlargement, male breast cancer, breast masses, nipple discharge, or unexplained breast changes.

Laboratory testing: Tell any healthcare provider or laboratory that you are using Pregnyl. Human chorionic gonadotropin may interfere with certain gonadotropin lab assays, especially tests involving luteinizing hormone.

Use in children and adolescents: Pregnyl should not be used in children or adolescents unless specifically prescribed by a qualified healthcare provider after appropriate evaluation. In pediatric patients treated for cryptorchidism, hCG may induce precocious puberty. Treatment should be discontinued if signs of precocious puberty occur.

Route of administration: Pregnyl is labeled for intramuscular use. Use Pregnyl only as instructed by your healthcare provider and pharmacy.

Seek emergency medical care if you experience trouble breathing, swelling of the face or throat, widespread rash, fainting, severe dizziness, chest pain, sudden shortness of breath, severe swelling, symptoms of stroke, or any sudden or severe symptom after using Pregnyl.

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 Pregnyl to make up for a missed dose. Do not change your dosing schedule without medical direction.

Overdose

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 with your prescription and pharmacy label.

Unopened Pregnyl should be stored at controlled room temperature, 15°C to 25°C / 59°F to 77°F. If the reconstituted solution is not used immediately, store it refrigerated at 2°C to 8°C / 36°F to 46°F and discard it after the time period listed on the prescription label or pharmacy instructions.

Do not freeze. Do not shake. Do not use Pregnyl if the solution is discolored, contains particles, appears contaminated, or looks unusual.

Keep Pregnyl and all injection supplies out of reach of children and pets.

Medication Disposal

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

Dispose of needles and syringes in an appropriate sharps container. Do not place loose needles directly into household trash.

Ask your pharmacist or local waste-disposal authority how to safely dispose of unused medication and injection supplies.

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, 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 Pregnyl. This page does not provide medical advice, diagnosis, or treatment.

Pregnyl is prescribed only when a licensed healthcare provider determines that it is medically appropriate. For questions about your medication, prescription, dosing, side effects, or treatment plan, contact your healthcare provider or pharmacist.