GANIRELIX ACETATE PREFILLED SYRINGE - INJECTION
Phonetic Pronunciation: (gah-nih-REE-lix)
Information last revised August 2010
What does GANIRELIX ACET PREFILLED SYR look like?
ganirelix 250 mcg/0.5 mL Sub-Q Syringe
Uses:
This medication is used as part of a treatment program for certain fertility problems in women. It is generally used in combination with other hormones (FSH and hCG). Ganirelix works by blocking the release of a certain hormone (luteinizing hormone). It helps delay ovulation and increases the chance of producing fertile eggs.
Missed Dose
It is important to use this medication at the correct schedule. If you miss a dose, contact your doctor or pharmacist immediately for instructions. Do not double the dose to catch up.
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 under the skin (subcutaneously) usually once daily, beginning several days after FSH injection is started, as directed by your doctor. Ganirelix and FSH injections are usually continued until the time of the hCG injection. You will be closely monitored by your doctor, who will determine the right time to discontinue ganirelix and FSH and to give the hCG injection. Follow your doctor's exact instructions on when to start and stop this medication. Discuss your treatment with your doctor if you have any questions. 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. It is important to change the location of the injection site daily to avoid discomfort or problem areas under the skin. 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. Use this medication exactly as directed by your doctor in order to get the most benefit from it. 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.
Drug Interactions
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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 duration of your therapy.
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.
Precautions
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing gonadotropin releasing hormone (GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Multiple births may occur because of this treatment program. Consult your doctor for more details. This medication must not be used during pregnancy because of possible harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Storage
Store the US product at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store the Canadian product between 59 and 86 degrees F (15 and 30 degrees C). Store the medication away from light and moisture. Do not store in the bathroom. Do not freeze. 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.
Side Effects
Redness or pain at the injection site, headache, mild nausea/stomach pain, and tiredness 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 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 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, or 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.
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.
The information contained in the First DataBank databases is intended to supplement the knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy problems and patient counselling information. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services. First DataBank disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose.
Copyright 2010 First DataBank, Inc.
