Lutropin Alfa

Registered South African indications: 

• Infertility

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Tumours of the hypothalamus and pituitary gland
• Ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
• Gynaecological haemorrhages of unknown origin
• Ovarian, uterine, or mammary carcinoma
• Conditions which make normal pregnancy impossible, such as: primary ovarian failure, malformations of sexual organs, incompatible with pregnancy, fibroid tumours of the uterus incompatible with pregnancy

Cautions

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Porphyria or a family history thereof
• Young age
• Lean body mass
• Polycystic ovarian syndrome
• Higher doses of exogenous gonadotropins
• High absolute or rapidly rising serum estradiol levels 
• Previous episodes of ovarian hyperstimulation syndrome
• Large number of developing ovarian follicles 
• Large number of oocytes retrieved in assisted reproductive technology cycles
• Previous abdominal surgery
• History of ovarian torsion
• Previous or current ovarian cyst 
• History of tubal disease
• Recent or ongoing thromboembolic disease or risk factors thereof
• Multiple treatment regimens

Forms avail. in SA and covered in this monograph: inj

Infertility
-Stimulation of follicular development in women with severe luteinising hormone (LH) and follicle stimulating hormone (FSH) deficiency

• SC: 75 IU, dly: Treatment duration: 5 week cycle

Initiated under the supervision of a physician experienced in the treatment of fertility problems

Treatment can commence at any time

Should be coadministered with FSH

Not established for use in children

Pregnancy 

• Contraindicated 
• There is no indication for the use of Lutropin Alfa during pregnancy
• Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation
• No teratogenic effect of Lutropin Alfa has been observed in animal studies
• In case of exposure during pregnancy, clinical data is not sufficient to exclude a teratogenic effect of Lutropin Alfa

Breastfeeding 

• Caution; Not recommended
• Lutropin Alfa is not indicated during breastfeeding

Fertility

• Lutropin Alfa is indicated for the stimulation of follicular development, in association with FSH

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Not indicated for use in geriatric patients

Central Nervous System Disorders

• Headache

Cardiovascular Disorders

• Thromboembolism

Gastrointestinal Disorders

• Abdominal pain/discomfort
• Nausea and vomiting
• Diarrhoea

Genitourinary Disorders

• Ovarian cyst
• Breast pain
• Pelvic pain
• Ovarian hyperstimulation syndrome

Skin and Subcutaneous Tissue Disorders

• Injection site reaction 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

No information available

None routine. Specific cases may require

• Albumin
• Electrolytes
• Fluid balance
• Hematocrit
• Haemoglobin
• Serum creatinine
• Urine output
• Hepatic function
• Signs and symptoms of ovarian hyperstimulation syndrome

Treatment with Lutropin Alfa should be initiated under the supervision of a physician experienced in the treatment of fertility problems

Lutropin alfa is a recombinant human luteinising hormone, a glycoprotein composed of non-covalently bound alpha- and beta-subunits. In the stimulation of follicular development in anovulatory women deficient in luitinizine hormone and follicle stimulating hormone (FSH), the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.

Injection (per vial) 75iu

• Luveris (Merck) originator

COMBINATION PREPARATIONS

Lutropin alfa/ Follitropin alfa

Injection (per vial) 75iu/150iu

• Pergoveris (Merck) originator