August 2018

New Product - Rekovelle

Follitropin delta (rhu) (Rekovelle) is a recombinant human follicle stimulating hormone (FSH). Differences in glycosylation profile, sialic acid pattern and isoform profile have been documented between Rekovelle and other recombinant FSH products, such as follitropin alfa and follitropin beta. Rekovelle is indicated in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Rekovelle is contraindicated with the following: tumours of the hypothalamus or pituitary gland; ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome; gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma; pregnancy and lactation. Rekovelle must not be used when an effective response cannot be obtained, such as: primary ovarian failure; malformations of sexual organs incompatible with pregnancy; fibroid tumours of the uterus incompatible with pregnancy. Rekovelle contains a potent gonadotropic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management. Rekovelle solution for injection prefilled multidose pen (containing an integrated non-replaceable 3 mL cartridge) is available in strengths of 12 microgram (pack of 1 prefilled pen and 3 injection needles), 36 microgram (pack of 1 prefilled pen and 6 injection needles), and 72 microgram (pack of 1 prefilled pen and 9 injection needles).

This list is a summary of only some of the changes that have occurred over the last month. Before prescribing, always refer to the full product information.

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