CinnaFact (Buserelin Acetate)

CinnaFact is the brand name of buserelin acetate.

In adult women, CinnaFact can be used for the following:

• Treatment of endometriosis (an illness where some of the tissues that line the womb are found elsewhere in the body).

• As part of a treatment for infertility. It works by stopping the natural production of hormones that control ovulation. Synthetic hormones are then used to stimulate ovulation artificially.

In adult men, CinnaFact is used to treat prostate cancer by lowering the amount of testosterone.

Do not use CinnaFact if:

• you are allergic to buserelin or other medicines such as goserelin, or any of the other ingredients of CinnaFact.
• you have a tumor that is not affected by changes in hormone levels
• you are a woman with abnormal menstrual bleeding
• you are a man who has had an operation to remove his testicles

Tell your doctor if you have any of the following:

• Any blood vessel or heart conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using CinnaFact.

• Tell your doctor if you are taking or have recently taken any other medicines.

• If you are pregnant or planning to become pregnant. CinnaFact may harm your unborn baby.

• If you are breastfeeding or planning to breastfeed. CinnaFact may pass into your breast milk.

In particular, tell your doctor if you are taking the following:

• Medicines for diabetes.

• Oral contraceptives.

• CinnaFact might interfere with some medicines used to treat heart rhythm problems (e.g., quinidine, amiodarone, procainamide, and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g., moxifloxacin, antipsychotics, methadone used for serious mental illnesses).

Your doctor will prescribe the dose that is right for you.

Tell your doctor right away if you have any of the following signs or symptoms:

Headache, hot flashes, vaginal dryness, decreased libido, menorrhagia (in women), impotence (in men), weakness, and back pain.

• Anemia: testosterone suppression may start with the development of anemia.

• CNS effects: may cause dizziness, which may impair mental or physical abilities.

• Decreased bone density: prolonged use of a luteinizing hormone-releasing hormone (LHRH) agonist may possibly lead to osteoporosis, cause decreased bone mineral density, and increase the risk of skeletal bone fracture.

• Disease fare: a transient exacerbation of the signs and symptoms of the disease process may be observed with the initiation of therapy in prostate cancer and endometriosis patients.

• Hypogonadism: hypogonadism is an effect of androgen deprivation therapy.

• Pituitary adenoma: pituitary adenomas may rarely be seen with long-term therapy.

• Cardiovascular disease: androgen-deprivation therapy may increase the risk for cardiovascular disease.

• Diabetes: loss of blood glucose control and reduced glucose tolerance have been noted in rare cases.

• Keep CinnaFact out of the reach of children.

• Do not freeze and do not expose it to heat.

• Keep CinnaFact away from light.

• Do not use it if the solution is leaking, cloudy, or has particles.

• CinnaFact should be kept at a temperature between 2°C and 25°C.

• Do not use CinnaFact after the expiration date.

• The product can be kept up to 20 days after the first opening when stored at room temperature.