Lutropin alfa is a hormone used to support Follicle Stimulating Hormone (FSH) therapy.
Lutropin alfa is used with follitropin alfa (Gonal-F) to stimulate a follicle(egg) to develop and
mature. The therapy used when a woman desires pregnancy and her ovaries can produce a follicle but
hormonal stimulation is not sufficient to make the follicle mature.
Lutropin alfa may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking lutropin alfa?
Lutropin alfa will not induce ovulation if the ovaries are not capable of producing an egg.
Before using this medication, tell your doctor if you
might be pregnant;
have a thyroid problem;
have adrenal dysfunction;
have cancer or a tumor of the breast, ovary, uterus,
hypothalamus, or pituitary gland;
have undiagnosed abnormal vaginal bleeding; or
have ovarian cysts or enlargement not due to polycystic
ovary disease (PCOD).
You may not be able to use lutropin alfa, or you may require a dosage
adjustment or special monitoring if you have any of the conditions listed above.
Treatment with lutropin alfa increases the likelihood of multiple births. Multiple births carry
additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your
healthcare provider.
Do not
use this medication if you are pregnant. Lutropin alfa is in the
FDA pregnancy category X. This means that lutropin alfa is known to cause birth defects in an unborn
baby (when used beyond the period of ovulation).
It is not known whether lutropin alfa passes into breast milk. Do not use lutropin alfa
without first talking to your doctor if you are breast-feeding a baby.
How should I take lutropin alfa?
Use lutropin alfa exactly as directed by your doctor. If you do not understand these directions,
ask your doctor, nurse, or pharmacist to explain them to you.
Lutropin alfa should only be administered subcutaneously. If you are administering this
medication at home, your doctor will give you detailed instructions on how to mix the solution and give
the injection. Do not inject this medication if you are not sure how.
Do not shake the vial, but gently swirl until the solution is clear. Do not inject any
medication that is discolored or that has particles in it.
Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate,
puncture-resistant disposal container.
Lutropin alfa should be used immediately after mixing. Any unused portion should be thrown
away.
What happens if I miss a dose of lutropin alfa?
Contact your doctor if you miss a dose of lutropin alfa.
Where can I get more information about lutropin alfa?
Your pharmacist has information about lutropin alfa written for health professionals that you may read.
What are the possible side effects of lutropin alfa?
Stop using lutropin alfa and seek emergency medical attention or notify your doctor
immediately if you experience any of the following serious side effects:
an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives);
pain, warmth, redness, numbness, or tingling in an arm or
leg (which may indicate a blood clot);
confusion, severe dizziness, severe headache; or
difficulty breathing.
Patients treated with lutropin alfa may develop ovarian hyperstimulation
syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic
pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low
urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or
seek emergency medical attention if you develop any of these symptoms.
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, diarrhea, or flatulence (gas);
fever or chills;
headache;
dizziness;
rapid pulse or heart rate;
muscle or joint weakness or aching;
breast tenderness;
spotting or menstrual changes;
pain, swelling, or irritation at the injection site; or
dry skin, a rash, or hair loss.
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. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about lutropin alfa?
Treatment with lutropin alfa increases the likelihood of multiple births. Multiple births carry
additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your
healthcare provider.
Patients treated with lutropin alfa may develop ovarian hyperstimulation syndrome (OHSS),
especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the
hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea,
and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency
medical attention if you develop any of these symptoms.
What should I avoid while taking lutropin alfa?
There are no restrictions on food, beverages, or activity during treatment with lutropin alfa
unless otherwise directed by your doctor.
What other drugs will affect lutropin alfa?
It is not known whether other medications will interact with lutropin alfa. Talk to your doctor
and pharmacist before taking any prescription or over-the-counter medicines, including vitamins,
minerals, and herbal products.
What happens if I have an overdose of lutropin alfa?
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.
Content provided by Multum - Last Updated 11/10/2009