Ovidrel

DRUG DESCRIPTION

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated ? and ? - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit). The primary structure of the ? - chain of r-hCG is identical to that of the ?- chain of hCG, FSH and LH. The glycoform pattern of the a - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The ? - chain has both O- and N glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG.

The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. This process yields a product with a high level of purity and consistent product characteristics including glycoforms and biological activity. The biological activity of choriogonadotropin alfa is determined using the seminal vesicle weight gain test in male rats described in the “Chorionic Gonadotrophins” monograph of the European Pharmacopoeia. The in vivo biological activity of choriogonadotropin alfa has been calibrated against the third international reference preparation IS75/587 for chorionic gonadotropin.

Ovidrel® (choriogonadotropin alfa injection) PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC) injection. Each Ovidrel® (choriogonadotropin alfa injection) PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5.

Therapeutic Class: Infertility

What are the precautions when taking choriogonadotropin alfa injection (Ovidrel)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unusual vaginal bleeding, problems of the uterus, certain type of fertility problem (primary ovarian failure), thyroid problem, adrenal gland problem, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), unexplained ovarian cyst/enlargement.

Tell your doctor your medical history, especially of: liver disease, blood...

Read All Potential Precautions of Ovidrel »


Ovidrel Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, mild abdominal pain/swelling, headache, and pain/bruising/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual vaginal bleeding.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment or after treatment is finished. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following very serious side effects: severe pain/swelling in the lower abdominal (pelvic) area, severe nausea/vomiting/diarrhea, sudden shortness of breath, sudden/rapid weight gain, decrease in the amount of urine.

Seek immediate medical attention if any of these very unlikely but very serious side effects occur: chest/jaw/left arm pain, sudden severe headache, confusion, weakness on one side of the body, slurred speech, swelling of the hands/ankles/feet, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling in the legs, sudden difficulty breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unusual vaginal bleeding, problems of the uterus, certain type of fertility problem (primary ovarian failure), thyroid problem, adrenal gland problem, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), unexplained ovarian cyst/enlargement.

Tell your doctor your medical history, especially of: liver disease, blood clots, stroke, heart disease (e.g., chest pain, heart attack), lung problems (e.g., asthma).

Successful treatment with this medication (pregnancy) may result in multiple births. Discuss the risks and benefits of having such a pregnancy with your doctor.

If you become pregnant or think you may be pregnant after treatment with this drug, stop using this medication and tell your doctor immediately. This drug must not be used during pregnancy because it may cause harm to an unborn baby.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.



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