Pregnyl

Pregnyl (human chorionic gonadotropin or hCG) is a prescription hormone injection used to trigger ovulation (the release of an egg) in women having fertility treatment. It is often called a trigger shot. Pregnyl is also used to treat low testosterone caused by a pituitary problem in males, and undescended testicles in young boys.

Pregnyl is given as an injection into a muscle by a healthcare provider, or by you after training. When used for ovulation induction, Pregnyl injection is given once, one day after the last dose of other gonadotropin medicines. It is made by Organon.

Pregnyl is used to help women ovulate and become pregnant as part of fertility treatment. It has 3 FDA-approved uses:

• Ovulation induction. Pregnyl triggers ovulation and supports pregnancy in women who do not ovulate on their own (anovulation). It is used only when the cause is not primary ovarian failure (ovaries that no longer work). It is given after a course of other gonadotropin medicines that help eggs grow. This single dose is often called a trigger shot.
• Hypogonadotropic hypogonadism in males. Pregnyl is used in selected males whose testes make too little testosterone because the pituitary gland does not make enough hormone.
• Prepubertal cryptorchidism. Pregnyl is used in boys whose testicles have not moved down into the scrotum (undescended testicles), when there is no physical blockage. Treatment usually starts between ages 4 and 9.

Pregnyl is not a weight-loss medicine. hCG has not been shown to help treat obesity. It does not increase weight loss, reduce hunger, or change where fat is stored on the body.

Pregnyl works by acting like luteinizing hormone (LH), a natural hormone from the pituitary gland. In women, it signals mature eggs to be released from the ovary and helps the ovary make progesterone after ovulation. In males, it signals the testes (Leydig cells) to make testosterone and other male hormones (androgens).

The hCG in Pregnyl is purified from the urine of pregnant people.

Pregnyl can cause serious side effects, especially when used for fertility treatment. It should be used only by a doctor experienced in treating infertility.

• Ovarian hyperstimulation syndrome (OHSS). The ovaries can become overstimulated, causing fluid to leak into the belly and chest. Severe OHSS can be life-threatening. It can start after treatment ends and is often worst about 7 to 10 days after treatment. Your provider should monitor you for at least 2 weeks after your Pregnyl dose. Get medical help right away if you have severe pelvic pain, nausea, vomiting, or sudden weight gain.
• Blood clots and lung problems. Serious lung problems and blood clots have been reported. These include clots in the legs or lungs (pulmonary embolism), stroke, and rarely heart attack. Your risk may be higher if you or a family member have had blood clots, have a clotting disorder (thrombophilia), or have severe obesity.
• Serious allergic reactions. Anaphylaxis has been reported with hCG made from urine.
• Twisting of the ovary (ovarian torsion). This has been reported after gonadotropin treatment. It may be linked to OHSS, pregnancy, past belly surgery, or ovarian cysts.
• Multiple pregnancy. Twins, triplets, or more have been reported with all gonadotropin treatments, including hCG.
• Pregnancy complications. Women having assisted reproductive treatment have a higher chance of ectopic pregnancy (a pregnancy outside the uterus). Miscarriage and birth defects may also be slightly more common. These risks may be related to the causes of infertility rather than the medicine itself.
• Ovarian tumors. Benign and cancerous ovarian tumors have been reported infrequently in women who used several fertility medicines. It is not known if these medicines caused them.
• Early puberty in boys. Boys treated for undescended testicles can start puberty too early (precocious puberty). Treatment should stop if signs of early puberty appear.

You should not use Pregnyl if you have:

• had an allergic reaction to hCG, other human gonadotropins, or any ingredient in Pregnyl
• high FSH levels showing your ovaries or testes have stopped working (primary gonadal failure)
• a thyroid, adrenal, or pituitary disorder that is not controlled
• a tumor of the hypothalamus, pituitary gland, ovary, breast, or uterus (females)
• a tumor of the breast or prostate (males)
• a problem with the shape of your reproductive organs, or uterine fibroids, that would make pregnancy impossible
• abnormal vaginal bleeding that has not been checked by a doctor

Tell your healthcare provider about all your health conditions, especially if you have:

• heart disease
• kidney disease
• high blood pressure
• epilepsy (seizures)
• migraine headaches
• asthma
• a personal or family history of blood clots, or a clotting disorder

Pregnyl can cause fluid retention by raising androgen levels, which can make some of these conditions worse.

Pregnancy. Pregnyl is not used during pregnancy. It may be used to support the second half of the menstrual cycle (luteal phase) during fertility treatment, but it is stopped once pregnancy is confirmed.

Breastfeeding. It is not known if hCG passes into breast milk. Talk with your provider about the benefits and risks before using Pregnyl while breastfeeding.

Lab tests. hCG can affect some hormone blood tests, especially tests for LH. Tell the lab that you are using Pregnyl.

Pregnyl is given as an injection into a muscle (intramuscular). It comes as a powder that must be mixed with the liquid supplied in the pack before use.

• Each multiple-dose vial is for one person only.
• For fertility treatment, your provider will check how your eggs are growing with ultrasound scans, and often blood tests for estradiol. These help time your Pregnyl dose and lower the risk of OHSS and multiple pregnancy.

Storage

• Before mixing: store at room temperature, 59°F to 77°F (15°C to 25°C).
• After mixing: store in the refrigerator at 36°F to 46°F (2°C to 8°C) if not used right away.
• Use mixed solution within 60 days. Do not freeze.

Pregnyl is mixed with the supplied solvent and injected into a muscle. Your healthcare provider will show you how to prepare and give the injection, and which injection site to use.

• Draw air out of the powder vial with a syringe and inject that air into the solvent vial.
• Draw up 1 to 10 mL of solvent, as your provider directs, and add it to the powder vial.
• Swirl gently until the powder dissolves. Do not shake the vial.
• Check the solution. Do not use it if it is cloudy, discolored, or has particles in it.
• Draw up your prescribed dose and inject it into a muscle (intramuscular injection).
• Store the rest of the mixed solution in the refrigerator and use it within 60 days.

Pregnyl is approved for intramuscular use only.

The usual dose of Pregnyl for ovulation induction is 5,000 to 10,000 USP units, given once, 1 day after the last dose of other gonadotropin medicines. Your dose depends on what you are being treated for and how you respond. Pregnyl comes in one strength, a multiple-dose vial of Pregnyl 10,000 units.

Your provider will choose the regimen that is right for you. Do not change your dose or timing without talking to them.

Common side effects of Pregnyl include headache, tiredness, irritability, and pain or bruising where the shot was given. The prescribing information does not give rates for how often each side effect happens.

Side effects in males and females

• headache
• irritability, restlessness, or depression
• tiredness (fatigue)
• swelling from fluid buildup (edema)
• injection site reactions such as bruising, pain, redness, swelling, itching, or rash
• rash or fever, rarely

Side effects in females

• belly pain, nausea, or diarrhea (signs of mild OHSS)
• enlarged ovaries or ovarian cysts
• breast pain
• weight gain, fluid in the belly (ascites), or fluid around the lungs (hydrothorax), which can be signs of severe OHSS
• blood clots, rarely, usually with severe OHSS

Side effects in males

• breast growth (gynecomastia), occasionally
• water and salt retention, occasionally with high doses
• early puberty in boys

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, or swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have:

• severe pelvic or stomach pain, nausea, vomiting, or fast weight gain
• little or no urination
• shortness of breath
• pain, warmth, or swelling in one leg
• chest pain, sudden numbness or weakness, or a severe headache

This is not a complete list of side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The Pregnyl prescribing information does not list any specific drug interactions. Tell your healthcare provider about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Pregnyl can affect some lab test results. hCG can cross-react in hormone blood tests, especially LH tests, so let the lab know you are using it.

After a Pregnyl injection, a home pregnancy test may show a positive result even if you are not pregnant, because these tests detect hCG. Ask your fertility team when it is best to test.

Each Pregnyl pack contains 1 vial of powder with 10,000 USP units of chorionic gonadotropin and 1 vial of liquid (solvent) for mixing.

• Active ingredient: chorionic gonadotropin (hCG)
• Inactive ingredients in the powder vial: dibasic sodium phosphate, monobasic sodium phosphate, and sodium hydroxide and/or phosphoric acid to adjust pH
• Solvent vial (10 mL): water for injection, sodium chloride 0.56%, benzyl alcohol 0.9% as a preservative, and sodium hydroxide and/or hydrochloric acid to adjust pH

The solvent contains benzyl alcohol, which is not for use in newborns.

Manufacturer: Organon. Powder vial NDC 78206-150-01; solvent vial NDC 78206-151-89.

Pregnyl is used in men and boys to raise testosterone when the pituitary gland does not make enough hormone, and to treat undescended testicles in young boys. It works by signaling the testes to make testosterone.

• Hypogonadotropic hypogonadism. Pregnyl is used in selected males whose low testosterone is caused by a pituitary problem (secondary hypogonadism), not by a problem with the testes themselves. Treatment can last several weeks to about 12 months, depending on the regimen.
• Undescended testicles (prepubertal cryptorchidism). Pregnyl is used in boys whose testicles have not moved into the scrotum, when there is no physical blockage. Treatment usually starts between ages 4 and 9 and lasts up to 6 weeks, with a second course sometimes given 1 month later.

Side effects that can affect males include breast growth (gynecomastia), fluid and salt retention with high doses, and early puberty in boys. Treatment should stop if signs of early puberty appear. See the dose table below for each regimen.