Lutropin alpha Solution for injection

What is this medicine?

LUTROPIN ALFA is a man-made hormone. It is used to treat women who have not been able to become pregnant because of problems with ovulation.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• abnormal or unusual vaginal bleeding
• asthma
• brain tumor or certain other kinds of cancer
• conditions affecting your adrenal gland or thyroid gland
• enlarged ovaries or ovarian cyst
• failure of the ovaries to produce eggs
• an unusual or allergic reaction to lutropin alfa, medicines, foods, dyes, or preservatives
• pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss a dose. If you are unable to keep an appointment, call your doctor or health care professional to reschedule. If you are injecting the drug yourself and you miss a dose, discuss with your doctor or health care professional when you should give your next dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chasteberry

This medicine may also interact with the following medications:

• herbal or dietary supplements, like blue cohosh or black cohosh

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You will be closely monitored by your doctor or health care professional. Contact your doctor or health care professional at once if you think you are pregnant. Your condition will still need to be monitored for at least two weeks after finishing this medicine.

If you are receiving this medicine to help you get pregnant, it is important to keep all records required by your doctor or health care professional such as daily basal body temperature (BBTs) and sexual intercourse. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant.

If abdominal pain occurs, discontinue treatment and call your doctor or health care professional immediately. Do not use the injection and avoid sexual intercourse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• abdominal bloating
• breast pain
• diarrhea
• gas
• nausea, vomiting
• severe abdominal pain
• swelling and rapid weight gain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• painful menstrual periods
• redness, pain, or swelling at site where injected
• stomach discomfort

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F) or at room temperature below 25 degrees C (77 degrees F). Do not freeze. Protect from light. Use immediately after mixing the powder. Discard any unused product. Throw away any unopened vials after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.