When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to chorionic gonadotropin (HCG), you have prostate cancer or similar kinds of cancer, or you are pregnant.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Use a new needle and syringe each time you inject your medicine.
• Missed dose:Call your doctor or pharmacist for instructions.
• This medicine comes as a powder that must be mixed with a liquid before you can use it. If you store this medicine at home, keep the dry powder at room temperature, away from heat, moisture, and direct light. After you mix the powder with the liquid, keep the mixture in the refrigerator. Do not freeze.
• You can keep the mixtures of Pregnyl® and Novarel™ in the refrigerator for up to 60 days. You can keep the mixture of Profasi® in the refrigerator for up to 30 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. Throw away old medicine after the expiration date has passed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are breastfeeding, or if you have heart disease, kidney disease, epilepsy, migraine headaches, or asthma.
• Talk to your doctor about the possibility that this medicine could cause you to get pregnant with twins, triplets, or multiple babies.
• The medicine may cause a boy to start puberty too soon. Call your doctor if your child starts to show signs of puberty while he uses this medicine. Some signs are acne, voice changes, getting taller too fast, or starting to grow hair in the armpit or on the face.
• This medicine contains benzyl alcohol. Tell your doctor if benzyl alcohol has ever made you sick.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, or coughing up blood
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your calf
• Severe nausea, vomiting, or pain in your pelvis
• Sudden or severe headache, problems with vision, speech, or walking
• Sudden weight gain or bloating

If you notice these less serious side effects, talk with your doctor:

• Feeling nervous, restless, or sad
• Pain where the shot is given
• Swelling in your hands, ankles, or feet
• Unusual tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088