IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CHORIOGONADOTROPIN ALFA INJECTION - PREFILLED SYRINGE

(KOR-ee-o-goe-nad-oh-troe-pin AL-fa)

COMMON BRAND NAME(S): Ovidrel

USES: This medication is used as part of a treatment program for certain fertility problems in women. It is generally used in combination with another hormone (FSH). This medication provides the hormone (hCG), which stimulates the release of a mature egg (ovulation) and helps you become pregnant. This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

HOW TO USE: Read the Patient Information Leaflet before starting this medication and each time you get a refill of this medication because new information may be available. You will be trained by a healthcare professional on how to properly use this medication. If any of the information is unclear, consult your healthcare professional. Inject this medication under the skin (subcutaneously) usually one day after your last dose of the hormone FSH, or as directed by your doctor. Follow your doctor's instruction closely to ensure proper timing of this medication. Wash hands with soap and water before using this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Inject the prescribed dose as directed by your doctor. Discard any unused portion of the medication immediately after the injection. Do not save it for future use. Do not change the dose unless instructed by your doctor or use this medication for a longer period than prescribed. Learn how to store and discard syringes, needles, and medical supplies safely. Consult your pharmacist for more information.

SIDE EFFECTS: Redness or pain at the injection site, mild abdominal pain, mood changes, or mild nausea/vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist 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 the following unlikely but very serious side effect occurs: unusual vaginal bleeding. Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden/severe headache, pain/swelling of the calf muscles, chest pain, shortness of breath, swelling of ankles/hands/feet. This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy and after treatment has been discontinued. 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 side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, change in the amount of urine. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 to other products containing chorionic gonadotropin (hCG); 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: other fertility problems (e.g., primary ovarian failure), thyroid or adrenal gland problems, cancer of the reproductive organs (e.g., breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), abnormal uterine/vaginal bleeding, unexplained ovarian cysts or enlarged ovaries. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, stroke, certain heart diseases (e.g., heart attacks), liver disease, lung problems (e.g., asthma). Multiple births may occur because of this treatment. Consult your doctor for more details. Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: gonadorelin. This medication may affect the results of certain lab tests (gonadotropin levels). Be sure to tell your doctor or laboratory personnel that you are taking this medication.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol levels, vaginal ultrasound) should be performed to monitor your progress and check for side effects. Consult your doctor for more details. It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of this medication.

MISSED DOSE: It is important to use this medication at the scheduled time. If you miss a dose and forget to use your medication, contact your doctor or pharmacist immediately for instructions. Do not double the dose to catch up.

STORAGE: Store the syringe refrigerated between 36-46 degrees F (2-8 degrees C). Brief storage is allowed at room temperature, 77 degrees F (25 degrees C), for up to 30 days. Protect from light. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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