Menotropins (injectable)

What is the most important information I should know about menotropins?

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

What are menotropins?

Menotropins are an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are important for the development of follicles (eggs) produced by the ovaries and for the development of sperm.

Menotropins are used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. Menotropins are also used to stimulate the development of multiple eggs for in vitro fertilization. Likewise, menotropins are used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient.

Menotropins may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using menotropins?

Menotropins will not induce ovulation or sperm production if your ovaries or testes are not functioning properly.

Do not use menotropins without first taking to your doctor if you

• might be pregnant;
• have a thyroid problem;
• have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;
• have undiagnosed vaginal bleeding;
• have ovarian cysts or enlargement; or
• have any other serious or chronic medical illness.

You may not be able to use menotropins, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Do not use menotropins if you are pregnant. Menotropins are in the FDA pregnancy category X. This means that they are known to cause birth defects.

It is not known whether menotropins pass into breast milk. Do not use menotropins without first talking to your doctor if you are breast-feeding a baby.

How should I use menotropins?

Use menotropins exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Formulations of menotropins intended for intramuscular injection (an injection into muscle) must not be administered subcutaneously (under the skin), and vice versa. If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give yourself the injection. Do not inject menotropins if you are not sure how.

Use the solution immediately after it is mixed. Throw away any medicine that is left over.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Store menotropins at room temperature or in the refrigerator, away from direct light, moisture, and heat.

What happens if I miss a dose?

Contact your doctor if you miss a dose of menotropins. Do not use a double dose of this medication without first talking to your doctor.

What happens if I overdose?

An overdose of menotropins is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice.

Symptoms of a menotropins overdose are not known. Ovarian hyperstimulation syndrome (OHSS) may result with an overdose of menotropins. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal.

What should I avoid while using menotropins?

There are no restrictions on food, beverages, or activity during therapy with menotropins unless your doctor directs otherwise.

What are the possible side effects of menotropins?

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Serious pulmonary (lung and breathing) conditions have been reported in patients using menotropins. Seek medical attention if you experience any sudden changes in your breathing.

Other side effects may also occur. Notify your doctor if you experience

• ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
• nausea, vomiting, or diarrhea;
• shortness of breath;
• pain, warmth, or tenderness centralized in an arm or leg;
• fever or chills;
• headache or drowsiness;
• weakness or aching of muscles or joints;
• breast enlargement or tenderness;
• pain, swelling, or irritation at the injection site; or
• rash.

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect menotropins?

It is not known whether other medications will interact with menotropins. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about menotropins written for health professionals that you may read.

What does my medication look like?

Menotropins is available with a prescription under the brand names Pergonal and Humegon. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Pergonal 75 IU powder for injection
• Pergonal 150 IU powder for injection
• Humegon 75 IU powder for injection
• Humegon 150 IU powder for injection

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 3.01. Revision date: 12/16/04.