CLOMID

What it is

Clomid is a tablet containing 50 mg clomifene citrate. The tablet is beige, scored on one side and engraved with an M into two concentric circles on the other side.

Approved indications

— Treatment of ovulatory failure in carefully selected infertile women who wish to become pregnant.

Dosing overview

The recommended dose for the first course of Clomid is 50 mg (one tablet) daily for five days. When ovulation occurs at this dosage there is no advantage in increasing the dose in subsequent cycles of treatment. If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for five days should be given. Increase of the dosage or duration of therapy beyond 100 mg daily for five days should not be undertaken. If ovulation occurs but is not followed by pregnancy, subsequent courses for a total maximum of six cycles of Clomid treatment may be administered. Long-term cyclic therapy beyond a total of about 6 cycles (including 3 ovulatory cycles) is not recommended.

Key safety warnings

Ovarian hyperstimulation syndrome (OHSS) has been reported in patients receiving Clomid therapy alone or in combination with gonadotrophins. Rare cases of severe forms of OHSS have been reported where symptoms have included pericardial effusion, anasarca, hydrothorax, acute abdomen, renal failure, pulmonary oedema, ovarian haemorrhage, deep venous thrombosis, torsion of the ovary and acute respiratory distress. To minimise the hazard of abnormal ovarian enlargement associated with Clomid therapy, patients should be given the smallest dose possible of Clomid consistent with an expectation of good results. Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata), partial or complete loss of vision may occasionally occur during or shortly after Clomid therapy. These visual disturbances are usually reversible; however, cases of prolonged or irreversible visual disturbances have been reported including after Clomid discontinuation. The visual disturbances may be irreversible, especially with increased dosage or duration of therapy. If they do occur Clomid should be discontinued and a complete ophthalmological evaluation should be made. No further courses of Clomid should be administered. Available data indicate that the use of clomifene citrate may increase the risk of ovarian cancer, especially in nulligravid women. Prolonged use of Clomid may increase the risk of developing a borderline or invasive ovarian tumour. Hypersensitivity reaction including anaphylaxis and angioedema have been reported with Clomid use.

Contraindications

Clomid is contraindicated in patients with known liver disease or a history of liver dysfunction. Clomid is contraindicated in patients with hormone-dependent tumours or in patients with abnormal uterine bleeding of undetermined origin. Clomid should not be administered during pregnancy. Clomid should not be given in the presence of an ovarian cyst, except polycystic ovary, since further enlargement of the cyst may occur. Clomid should not be given if history of significant, medically confirmed, vision disorders related to the use of Clomid (prior or ongoing treatment) is known.

PBS listing

Clomid 50 mg tablet is listed on the PBS with one item, subject to restriction. The ex-manufacturer price is A$20.15.

Regulatory history

Clomid was first approved on 8 July 1991. The current ARTG registration (ARTG 313131) for Clomid clomifene citrate 50 mg tablet blister pack was first listed on 8 August 2019.