Microrelin® 11.25 mg

Description

MICRORELIN ® is a Synthetic agonist of GnRH that possesses greater potency than the natural hormone. Gonadotrophin Releasing Hormone (GnRH) released from the Hypothalamus is responsible for the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary.

MICRORELIN ® has a sustained-release formulation that allows continuous release of the drug over 28 days. Naturally, GnRH Secretion is Pulsatile to Stimulate the secretion of Sex hormones. When it is given continuously in therapeutic doses, there is an initial and transient increase in circulating levels of LH, FSH, and Testosterone. Continued administration of MICRORELIN ® results in an inhibition of pituitary Sex Hormones by 95%.

MICRORELIN ® API is manufactured in Bachem Co. Switzerland and Corbion Co. Netherlands, microsphere and QC tests were developed and done by Primm Co., Italy, and Homa Pharmed Co. produces the final product.

MICRORELIN ® is provided as a lyophilized powder in 5 ml glass containing 3.75 Triptorelin acetate within microparticles and additives. Plus, an ampule containing 2 ml of vehicle for reconstitution of powder for IM Injection.

Labeled Indications

• Treatment of advanced Prostate cancer
• Treatment of pediatric patients with central precocious puberty
• For use in the management of endometriosis, either as monotherapy (for pain relief and reduction of endometriotic lesions) or as combination therapy with Uterine fibroids with add-back therapy (to reduce bone mineral density loss and reduce vasomotor symptoms)
• For use in combination with iron for the preoperative hematologic improvement of patients with anemia caused by fibroids when 3 months of hormonal suppression is deemed necessary.
• Adjuvant treatment in breast cancer
• Treatment of paraphilia/hypersexuality

Administration

MICRORELIN ® should be administered by a trained healthcare provider. It is essential to follow the mixing instructions including in the packaging, closely.

MICRORELIN ® should be administrated intramuscularly in the gluteal region at 12-week intervals (84 days) and administration intervals should not be more than 12 weeks.

Side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

during the first month of administration there is a transient increase in sex hormones thus may worsen some of your symptoms but this effect will go away after the first 28 days as continuous administration of the drug at the prescribed date.

The most commonly observed adverse events during triptorelin treatment are due to the expected physiological effects related to decreased testosterone and estrogen levels. These effects included hot flushes, erectile dysfunction, and decreased libido. Other side effects are weakness and/or paresthesia of the lower limbs, allergic reaction, nausea, vomiting, weight gain, hypertension, mood disorders, visual disturbances, fever, or pain at the injection site.

Special warning & Precautions

Hypersensitivity to triptorelin or any of its components, pregnancy.

Pregnancy and lactation:

Hormonal changes that occur with therapy may increase the risk of pregnancy loss. Therefore, use is contraindicated during pregnancy.

It is not known if triptorelin is present in breast milk.

Due to the potential for adverse reactions in the breastfed infant, the manufacturer recommends that a decision be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.

Storage

MICRORELIN ® should be stored between 15-25°C (room temperature).

Keep away from children.