Ovidrel

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using HCG.

Your doctor or pharmacist can provide more information about HCG.

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.

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• EMD Serono, Inc.

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.

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.

Gonad-stimulating hormone; biosynthetic (recombinant DNA-derived) form of human chorionic gonadotropin (hCG).1

Female Infertility

Used in conjunction with other infertility agents (e.g., gonadotropin-releasing hormone agonist, FSH) for induction of final follicular maturation and early luteinization in ovulatory, infertile women during assisted reproductive technology (ART) programs.1 2 3 6 7 8 9

Use in patients with tubal obstruction only if participating in ART programs.1

Choriogonadotropin alfa (r-hCG) is equivalent to urinary-derived hCG with regard to number of oocytes recovered, fertilized oocytes or embryos, and live births.1 2 3

Used in conjunction with follicle-stimulating agent to induce ovulation in anovulatory, infertile women in whom anovulation is functional and not due to primary ovarian failure.1 4 5 h

Choriogonadotropin alfa (r-hCG) is similar to urinary-derived hCG with regard to ovulation rates.1 h

No formal drug interaction studies to date.1

Laboratory Tests

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Bloating (mild)
• stomach or pelvic pain

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• swelling of feet or lower legs
• weight gain (rapid)

• Acne
• enlargement of penis and testes
• growth of pubic hair
• increase in height (rapid)

• difficult or labored breathing
• difficulty breathing
• flushing of skin
• hives or welts
• itching of skin
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• pain in chest, groin, or legs, especially the calves
• redness of skin
• severe, sudden headache
• skin rash
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in arm or leg
• sudden, unexplained shortness of breath
• tightness in chest
• unusually warm skin
• vision changes
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Discouragement
• enlargement of breasts
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• pain at place of injection
• trouble concentrating
• trouble sleeping
• tiredness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.
• Your doctor may teach you how to give the shot.
• Follow how to use carefully.
• Wash your hands before and after use.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.