Chemical formula: C₆₆H₈₃N₁₇O₁₃ Molecular mass: 1,322.496 g/mol PubChem compound: 25077405
When administered intramuscularly to rats on days 6-15 of pregnancy at doses of 0.4, 1.6 and 6.4 mcg/kg/day (0.6, 2.5 and 10.0 times the intranasal human dose of 400mcg per day), 4/80 fetuses in the highest dose group had major fetal abnormalities that were not seen in a repeat study in rats. Moreover, studies in mice and rabbits failed to demonstrate an increase in fetal abnormalities. In rats, there was a dose-related increase in fetal mortality, and a decrease in fetal weight with the highest dose. These effects on rat fetal mortality are logical consequences of the alterations in hormonal levels brought about by nafarelin in this species.
Use of nafarelin in human pregnancy has not been studied.
Nafarelin should not therefore be used during pregnancy or suspected pregnancy. Before starting treatment with nafarelin pregnancy must be excluded. If a patient becomes pregnant during treatment, administration of the drug must be discontinued and the patient must be informed of a potential risk to fetal development.
Controlled ovarian stimulation prior to in vitro fertilisation: Pregnancy should be excluded before starting treatment with nafarelin, and the medication should be stopped on the day of administration of hCG. Barrier methods of contraception should be employed whilst nafarelin is being taken.
It is not known whether or to what extent nafarelin is excreted into human breast milk. The effects, if any on the breast-fed child have not been determined and therefore nafarelin should not be used by breast-feeding women.
Not applicable.
Initial treatment with nafarelin acetate may cause transient exacerbation of endometriosis and chronic treatment may induce a menopausal state. The following undesirable effects have been observed and reported during treatment of 282 adult patients with nafarelin acetate with the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Not known: Cannot be estimated from the available data.
Common: Drug hypersensitivity (Chest pain, Dyspnoea, Pruritus, Rash, Urticaria)
Common: Oestrogen deficiency
Very common: Weight increased
Common: Weight decreased
Very common: Affect lability, Libido decreased
Common: Depression, Insomnia, Libido increased
Very common: Headache
Common: Paraesthesia
Very common: Hot flush
Common: Hypertension, Hypotension
Very common: Rhinitis
Very common: Acne, Seborrhoea
Common: Hirsutism
Uncommon: Alopecia
Very common: Myalgia
Uncommon: Arthralgia
Very common: Breast atrophy, Vulvovaginal dryness
Common: Artificial menopause, Uterine haemorrhage
Uncommon: Breast enlargement, Ovarian cyst
Not known: Ovarian hyperstimulation syndrome
Very common: Oedema
Common: Bone density decreased
In addition to the above mentioned undesirable affects, migraine, blurred vision, palpitations, shortness of breath, increased levels of SGOT/SGPT and serum alkaline phosphatase have been reported but the frequencies are not known.
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