Duinum Warnings

General: Good levels of endogenous oestrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary oestrogen, or endometrial bleeding in response to progesterone) provide a favourable prognosis for ovulatory response induced by Duinum. A low level of oestrogen, although clinically less favourable, does not preclude successful outcome of therapy. Duinum therapy is ineffective in patients with primary pituitary or primary ovarian failure. Duinum therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure, such as thyroid or adrenal disorders. For hyperprolactinaemia there is other preferred specific treatment. Duinum is not first line treatment for low weight related amenorrhoea, with infertility, and has no value if a high FSH blood level is observed following an early menopause.
Ovarian Hyperstimulation Syndrome: Ovarian Hyperstimulation Syndrome (OHSS) has been reported in patients receiving Duinum therapy for ovulation induction. In some cases, OHSS occurred following the cyclic use of Duinum therapy or when Duinum was used in combination with gonadotropins. The following symptoms have been reported in association with this syndrome during Duinum therapy: pericardial effusion, anasarca, hydrothorax, acute abdomen, renal failure, pulmonary oedema, ovarian haemorrhage, deep venous thrombosis, torsion of the ovary and acute respiratory distress. If conception results, rapid progression to the severe form of the syndrome may occur.
To minimise the hazard of the abnormal ovarian enlargement associated with Duinum therapy, the lowest dose consistent with expectation of good results should be used. The patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort or distension after taking Duinum. Maximal enlargement of the ovary may not occur until several days after discontinuation of the course of Duinum. Some patients with polycystic ovary syndrome who are unusually sensitive to gonadotropin may have an exaggerated response to usual doses of Duinum.
The patient who complains of abdominal or pelvic pain, discomfort, or distension after taking Duinum should be examined because of the possible presence of an ovarian cyst or other cause. Due to fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be performed very cautiously. If abnormal enlargement occurs Duinum should not be given until the ovaries have returned to pre-treatment size. Ovarian enlargement and cyst formation associated with Duinum therapy usually regresses spontaneously within a few days or weeks after discontinuing treatment. Most of these patients should be managed conservatively. The dosage and/or duration of the next course of treatment should be reduced.
Visual symptoms: Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata) may occasionally occur during or shortly after therapy with Duinum.
These visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported including after clomifene discontinuation. The visual disturbances may be irreversible especially with increased dosage or duration of therapy. The significance of these visual symptoms is not understood. If the patient has any visual symptoms, treatment should be discontinued and ophthalmologic evaluation performed.
Patients should be warned that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting.