Choriogonadotropin Alfa

Choriogonadotropin Alfa is a prescription medication used to promote descent of the testicles in young boys, boost hormone levels in men, and promote pregnancy in women. Choriogonadotropin Alfa belongs to a group of drugs called synthetic hormones and works by mimicking the effects of FSH and LH, which are naturally occurring hormones in the body.

This medication is available in an injectable form to be given directly into a muscle by a healthcare professional on a dosing schedule that is determined by several medical factors.

Common side effects of Choriogonadotropin Alfa include headache, restlessness, and fatigue.

Choriogonadotropin Alfa can also cause drowsiness. Do not drive or operate heavy machinery until you know how Choriogonadotropin Alfa affects you.

Choriogonadotropin Alfa is a prescription medication used to promote descent of the testicles in young boys, boost hormone levels in deficient men, and promote pregnancy and ovulation in women.

Choriogonadotropin Alfa has not been demonstrated to increase weight loss or otherwise treat obesity.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Choriogonadotropin Alfa may be found in some form under the following brand names:

• A.p.l.

• Chorex

• Chorigon

• Gonic

• Novarel

• Ovidrel

• Pregnyl

• Profasi

Serious side effects have been reported with Choriogonadotropin Alfa. See the “Choriogonadotropin Alfa Precautions” section.

Common side effects of Choriogonadotropin Alfa include the following:

• headache
• restlessness
• fatigue
• swelling of the extremities
• swelling of breast tissue in men and women
• pain at the site of injection

This is not a complete list of Choriogonadotropin Alfa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• follicle stimulating hormone
• ganirelix

This is not a complete list of Choriogonadotropin Alfa drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Choriogonadotropin Alfa including the following:

• Life-threatening allergic reactions. Discontinue using Choriogonadotropin Alfa and get medical attention immediately if you experience facial, lip, tongue, or throat swelling and/or difficulty breathing.
• Ovarian Hyperstimulation Syndrome. Discontinue use of Choriogonadotropin Alfa and get medical attention immediately if you experience the following combination of symptoms:
  • severe pelvic pain
  • nausea
  • vomiting
  • weight gain
• Blood clots. Consult with your physician if you have a history of heart disease and/or blood clots. Discontinue using Choriogonadotropin Alfa and get medical attention immediately if you experience sudden difficulty breathing, persistent leg or other extremity pain and/or sudden severe headaches.
• Full body swelling. Discontinue using Choriogonadotropin Alfa and get medical attention immediately if you experience abnormal swelling of your extremities and abdomen.
• Fluid in the lungs. Discontinue using Choriogonadotropin Alfa and get medical attention immediately if you experience sudden difficultly breathing.
• Early-onset puberty. Discontinue using Choriogonadotropin Alfa and get medical attention immediately if you or your child experiences symptoms of early-onset puberty including increased hair growth and thickening, deepening of the voice, acne, early breast development, and/or rapid height growth.
• Depression. Consult with your physician if you have or have had a history of depression or any other psychiatric issues.

Do not take Choriogonadotropin Alfa if you:

• Are allergic to Choriogonadotropin Alfa or to any of its ingredients
• Have early-onset puberty
• Have prostate cancer
• Have other cancers that are stimulated by androgens

Choriogonadotropin Alfa can also cause drowsiness. Do not drive or operate heavy machinery until you know how Choriogonadotropin Alfa affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Choriogonadotropin Alfa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Gonal-F, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Gonal-F or to any of its ingredients
• have heart disease or history of heart disease
• have early onset puberty
• have kidney disease
• have epilepsy
• have asthma
• have migraine headaches
• have any type of active cancer
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Choriogonadotropin Alfa falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Choriogonadotropin Alfa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Choriogonadotropin Alfa.

Use Choriogonadotropin Alfa exactly as prescribed.

Choriogonadotropin Alfa is available in an injectable form to be given directly into a muscle by a healthcare professional. It is typically given three to four times per week when used to promote descent of the testicles, two to three times per week when used to boost hormone levels in men, and as one dose per treatment when used to promote pregnancy in women.

Choriogonadotropin Alfa has not been demonstrated to increase weight loss or otherwise treat obesity.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age
• your gender

The recommended dose range of Choriogonadotropin Alfa when used to promote pregnancy and ovulation in women is 5,000 international units (IU) to 10,000 IU injected intramuscularly once per treatment.

The recommended dose range of Choriogonadotropin Alfa when used to promote descent of the testicles in boys is 500 IU to 5,000 IU injected intramuscularly three to four times per week.

The recommended dose range of Choriogonadotropin Alfa when used to boost hormone levels in men is 500 IU to 2,000 IU injected intramuscularly two to three times per week.

If you receive too much Choriogonadotropin Alfa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 20° to 25°C (68° to 77°F)
• Keep this and all medicines out of the reach of children