Ovidrel

Ovidrel is a prescription medication used to promote ovulation and pregnancy in women who are having difficulty getting pregnant. Ovidrel belongs to a group of drugs called synthetic hormones, which work by helping to balance the levels of natural hormones in the body.

This medication comes as an injection and is given directly under the skin once per treatment.

Common side effects of Ovidrel include injection site pain, stomach upset, and nausea.

Ovidrel can also cause dizziness. Do not drive or operate heavy machinery until you know how Ovidrel affects you.

Ovidrel is a prescription medication used to promote ovulation and pregnancy in women who are participating in in-vitro fertilization, embryo transfer, or who are infertile with functional ovaries.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• EMD Serono, Inc.

Serious side effects have been reported with Ovidrel. See the “Ovidrel Precautions” section.

Common side effects of Ovidrel include the following:

• pain and/or bruising at the site of injection
• headache
• nausea
• abdominal pain
• diarrhea
• ovarian cysts

This is not a complete list of Ovidrel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Ovidrel may interfere with pregnancy tests.

Serious side effects have been reported with Pregnyl including the following:

• Ovarian Hyperstimulation Syndrome (OHSS). Discontinue using Ovidrel and get medical attention immediately if you experience severe pelvic pain, nausea, vomiting, and/or weight gain.
• Hyperstimulation and/or enlargement of the ovaries. Discontinue using Ovidrel and get medical attention immediately if you experience abnormal severe abdominal pain.
• Life-threatening allergic reactions. Discontinue using Ovidrel and get medical attention immediately if you experience facial, lip, tongue, throat swelling and/or difficulty breathing.
• Fluid in the lungs. Discontinue using Ovidrel and get medical attention immediately if you experience sudden difficultly breathing.

Do not take Ovidrel if you:

• Are allergic to Ovidrel or to any of its ingredients
• Have nonfunctional ovaries
• Have thyroid or adrenal gland disease.
• Have brain tumors
• Have unusual vaginal bleeding
• Have ovarian cysts
• Are pregnant

Ovidrel can also cause dizziness. Do not drive or operate heavy machinery until you know how Ovidrel affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ovidrel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Ovidrel, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Ovidrel or to any of its ingredients
• have thyroid or adrenal gland disease
• have a brain tumor
• have unusual vaginal bleeding
• have nonfunctional ovaries or ovarian cysts
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ovidrel falls into category X. It has been shown that women taking Ovidrel during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ovidrel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ovidrel.

Use Ovidrel exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin (SC) once per treatment.

Before treatment is started, a thorough gynecology and endocrine evaluation must be performed by a physician. Evaluation of your partner's fertility potential should be included in the initial evaluation.

Ovidrel may be self-administered if recommended by your physician. Your physician will instruct you on how to properly inject Ovidrel. Follow the directions below for additional information on how to self-inject Ovidrel:

1. Wash your hands thoroughly with soap and water
2. Make yourself comfortable by sitting or lying down. Carefully clean the injection site on the stomach with an alcohol wipe and allow it to air-dry
3. Carefully remove the needle cap from the syringe. Do not touch the needle or allow the needle to touch any surface. Inject the prescribed dose as directed by your doctor, nurse or pharmacist
4. Gently withdraw the needle
5. Discard the needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage
6. Remember that your injection materials must be kept sterile and cannot be reused

If you miss a dose, make an appointment to receive the missed dose or administer the missed dose as soon as you remember.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Ovidrel to promote ovulation and pregnancy in women who are participating in in-vitro fertilization, embryo transfer, or who are infertile with functional ovaries is 250 micrograms given once per treatment.

If you take too much Ovidrel, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Ovidrel is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Ovidrel must be stored refrigerated between 2-8°C (36-46°F)
• Protect from light.
• Store in original package. Discard unused material.
• Keep this and all medicines out of the reach of children.