Important Safety Information: Pregnyl® (chorionic gonadotropin) | Injection

What is this?

This Important Safety Information summarizes key warnings and precautions for Pregnyl (chorionic gonadotropin, hCG), an FDA-approved prescription medication given by intramuscular injection after mixing (reconstitution). hCG acts similarly to the body’s natural luteinizing hormone (LH).

Pregnyl may be used:

• In males: in selected cases of hypogonadotropic hypogonadism (low gonadotropins due to pituitary-related deficiency).

• In females: to help trigger ovulation as part of certain fertility treatment protocols, after appropriate evaluation and treatment with gonadotropins.

• In pediatrics: for prepubertal cryptorchidism (undescended testicle) not due to anatomical obstruction.

Important: hCG has not been shown to help with obesity or weight loss and does not reduce hunger or change body fat distribution.

This summary does not include all available information. Always read your medication label and follow your provider’s instructions.

Most Serious Warnings

Pregnyl can cause serious risks, including:

• Severe allergic reactions, including anaphylaxis

• Ovarian Hyperstimulation Syndrome (OHSS) in females using fertility medications, which can become life-threatening

• Blood clots (thromboembolic events), which may occur with or without OHSS and can rarely be fatal

• Serious lung problems (including fluid around the lungs or acute breathing issues), most often reported with fertility treatment

• Ovarian torsion (twisting of the ovary), which is a medical emergency

• Multiple gestation (twins or more) when used in fertility treatment

• Ectopic pregnancy (pregnancy outside the uterus) in patients using assisted reproductive technologies

• Fluid retention due to increased androgen production (more relevant at higher doses, especially in males)

Solvent warning: The Pregnyl solvent contains benzyl alcohol and is not for use in newborns.

Who Should NOT Take Pregnyl

Do not use Pregnyl if you:

• Have had an allergic reaction to hCG or other human gonadotropins, or any ingredient in the product

• Have uncontrolled non-gonadal endocrine disorders (such as uncontrolled thyroid, adrenal, or pituitary disorders)

• Have certain hormone-sensitive tumors, including tumors of:

• Hypothalamus or pituitary

• Ovary, breast, or uterus (females)

• Breast or prostate (males)

• Are a female with high FSH levels suggesting primary ovarian failure

• Have abnormal vaginal bleeding with an unknown cause

• Have reproductive organ abnormalities or uterine fibroids that make pregnancy unsafe or unlikely to succeed

Before Taking Pregnyl, Tell Your Healthcare Provider if You:

• Have a history of blood clots, clotting disorders (thrombophilia), severe obesity, or a strong family history of clots

• Have heart disease, kidney disease, high blood pressure, epilepsy, migraine, or asthma (Pregnyl can cause fluid retention)

• Are undergoing fertility treatment and have risk factors for high ovarian response or OHSS

• Are pregnant, think you may be pregnant, or are breastfeeding

• Take any prescription or over-the-counter medicines, vitamins, or supplements

• Have any concerns about cancers that may be sensitive to hormones (such as prostate, breast, uterine, or ovarian cancers)

Possible Side Effects

Common (mild to moderate):

• Injection site reactions (pain, redness, swelling, itching, bruising)

• Headache

• Fatigue

• Swelling (edema)

• Mood changes (irritability, restlessness, depression)

• In males: breast tenderness or enlargement (gynecomastia) can occur

Serious (seek medical care immediately):

• Allergic reaction symptoms: hives, rash, fever, swelling of face or throat, trouble breathing

• Signs of a blood clot: leg pain or swelling, chest pain, shortness of breath, sudden weakness, severe headache, vision or speech changes

• In females receiving fertility treatment: symptoms of OHSS, including severe pelvic or abdominal pain, rapid weight gain, nausea/vomiting, shortness of breath, decreased urination, or significant abdominal swelling

• Sudden severe pelvic pain (possible ovarian torsion)

While Taking Pregnyl

Contact your provider right away if you develop:

• Shortness of breath, chest pain, or one-sided leg swelling

• Severe headache, sudden vision changes, confusion, or weakness

• Severe pelvic or abdominal pain, rapid weight gain, or persistent nausea/vomiting (especially during fertility treatment)

• Signs of an allergic reaction

• In children treated for undescended testicle: signs of early puberty (precocious puberty)

Pregnancy and Fertility

• Pregnyl is not indicated for use during pregnancy. In some fertility protocols, it may be used briefly for luteal support but is typically discontinued once pregnancy is confirmed.

• Fertility treatment using gonadotropins can increase the risk of multiple births, ectopic pregnancy, and miscarriage. Early ultrasound is important to confirm the pregnancy is in the uterus.

Overdose

If too much is used, risks may increase. Seek urgent medical care if you have severe symptoms such as:

• Severe pelvic or abdominal pain, rapid swelling or weight gain

• Shortness of breath

• Signs of blood clots or severe allergic reaction

Missed Dose

If you miss a dose:

• Do not double the next dose

• Contact your prescribing provider for instructions

Storage

• Store unopened vials at room temperature as directed on the label.

• After mixing, refrigerate as directed. Do not freeze.

• Use the mixed solution only within the timeframe listed on the product instructions and your provider’s guidance. Discard if it is discolored or contains particles.

Medication Disposal

Dispose of unused medication and sharps (needles, syringes) using approved sharps containers and local disposal guidance. Ask your pharmacy about take-back options.

Provider Oversight and Monitoring

Pregnyl dosing and timing depend on your medical goals and must be supervised by a licensed clinician. In fertility treatment, monitoring may include ultrasound and lab testing to reduce the risk of OHSS and multiple gestation.

Telemedicine Disclosure

If Pregnyl is prescribed via telemedicine and you experience severe or concerning symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about Pregnyl and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.