Novarel (injectable)

Novarel is a hormone that helps trigger ovulation and treats infertility in women. Novarel is not effective in women with primary ovarian failure.

HCG is used in men to treat hypogonadism, a condition where the body does not produce enough testosterone.

HCG is also used in young boys whose testicles have not descended into the scrotum as expected during growth. HCG is usually given for this condition in boys aged 4 to 9 years.

HCG is not approved for weight loss and has not been shown to work better than simply eating fewer calories.

HCG may also be used for reasons not mentioned in this medication guide.

HCG can lead to serious side effects. Contact your doctor immediately if you experience: severe stomach pain or bloating, swelling, rapid weight gain, chest pain, difficulty breathing, severe nausea and vomiting, reduced urination, pain or swelling in one leg, or sudden numbness on one side of your body.

You should not use HCG if you are allergic to it, or if you have:

• early puberty (precocious puberty); or
• a hormone-related cancer (such as prostate cancer).

You also may not be able to use certain brands of HCG if you have:

• an uncontrolled disorder of your thyroid or adrenal gland;
• abnormal vaginal bleeding that has not been checked by a doctor;
• an ovarian cyst; or
• cancer or a tumor of the breast, ovary, uterus, prostate, hypothalamus, or pituitary gland.

Tell your doctor if you have ever had:

• heart disease;
• kidney disease;
• problems with your thyroid or adrenal gland;
• epilepsy;
• migraines; or
• asthma.

May harm an unborn baby. Do not use if you are already pregnant. You may need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant.

Fertility treatment may increase your chance of having multiple births (twins, triplets, etc). These are high-risk pregnancies for both the mother and the babies. Talk to your doctor if you have concerns about this risk.

Ask a doctor if it is safe to breastfeed while using Novarel.

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

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), which can be life-threatening. Call your doctor right away if you have symptoms of OHSS:

• severe stomach pain or pelvic pain;
• rapid weight gain, swelling around your waist, shortness of breath;
• severe nausea and vomiting, diarrhea; or
• little or no urination.

Novarel may cause serious side effects. Call your doctor immediately if you have:

• fluid build-up around the lungs or stomach—rapid weight gain, stomach pain and bloating, pain when you breathe, shortness of breath while lying down, cough with foamy mucus, rapid heartbeats;
• signs of a blood clot—sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg; or
• early puberty in boys—enlarged testicles and penis, facial hair, a deepened voice.

Common side effects of Novarel may include:

• headache, depression;
• feeling restless or irritable;
• swelling;
• breast tenderness or swelling; or
• pain where the medicine was injected.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

HCG is not for daily use. How often you use this medicine depends on the condition you are treating. You may need medical tests to help determine how long you should use HCG.

HCG is injected into a muscle or under the skin. Ask your doctor or pharmacist if you don't understand how to use an injection.

Be sure you understand how to properly mix this medicine with a liquid (diluent) if needed.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using HCG.

Store unmixed HCG and diluent at room temperature away from moisture and heat.

Store mixed medicine in the refrigerator. Use mixed Novarel within 30 days. Use mixed Pregnyl within 60 days. Call your pharmacist if the medicine has changed colors or has particles in it.

Storing a prefilled syringe (Ovidrel):

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 30 days.

Carefully follow the mixing, storage, and expiration instructions that come with the brand of HCG you are using.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Call your doctor for guidance if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect HCG, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.