New injection approved to treat infertility

June 3, 2002

The US Food and Drug Administration (FDA) recently approved urofollitropin for injection, purified (Bravelle, Ferring Pharmaceuticals) for the treatment of infertility. Urofollitropin is a highly purified follicle-stimulating hormone derived from the urine of postmenopausal women

 

Rx CARE

New injection approved to treat infertility

The Food & Drug Administration recently approved urofollitropin for injection, purified (Bravelle, Ferring Pharmaceuticals) for the treatment of infertility. Urofollitropin is a highly purified follicle- stimulating hormone derived from the urine of postmenopausal women, said Lynn Westphal, M.D., assistant professor of gynecology and obstetrics, Stanford University Medical Center, Stanford, Calif.

Bravelle can be used in any woman who requires gonadotropins to induce ovulation, said Westphal, but it should be used only in women who are healthy enough to try to achieve pregnancy. She explained that Bravelle causes multiple follicles to develop in the ovaries of women without primary ovarian failure. Human chorionic gonadotropin is then administered to induce ovulation.

The use of Bravelle is contraindicated in women who have primary ovarian failure or are infertile for any reason other than anovulation, said Gene Memoli, R.Ph., senior v.p., Pharmaceutical Care, The Medicine Centre/LTC, Portland, Conn. Its use is also contraindicated in pregnant women, those with an organic intracranial lesion (e.g., a pituitary tumor), and women with uncontrolled thyroid or renal dysfunction. Other contraindications are abnormal bleeding of undetermined origin and ovarian cysts or enlarged ovaries not caused by polycystic ovary syndrome.

Westphal cautioned that Bravelle should be prescribed only by physicians who are familiar with medications used in the treatment of infertility, because the drug can cause ovarian hyperstimulation syndrome (OHSS), a potentially serious condition. If the ovaries are hyperstimulated, they could become enlarged, she said. The woman can retain fluid in her abdomen and, in severe cases, become very ill and require hospitalization.

Severe pelvic discomfort, nausea, vomiting, and weight gain are early warning signs of OHSS, said Memoli. Symptoms reported in cases of OHSS include nausea, vomiting, and diarrhea; abdominal pain and abdominal distention; severe enlargement of the ovaries; weight gain; dyspnea; and oliguria. Memoli said he feels OHSS is not the significant problem it has been in the past, because patients on fertility drugs are now monitored much more closely than in previous years.

Bravelle is administered as either an intramuscular (IM) or a subcutaneous (SC) injection. Patients usually take the drug in the first two weeks of their cycle or the first two weeks of an in vitro fertilization cycle, explained Westphal. Bravelle is given for seven to 12 days. The recommended initial dose is 150 IU daily for the first five days; subsequently, dosing is individualized and based on therapeutic response.

The advantage of Bravelle over existing products is still to be determined, said Westphal. One advantage may be that it is much purer than Repronex (Ferring Pharmaceuticals), which also contains luteinizing hormone (LH), and thus may be less irritating to patients. Any additional advantage, she continued, depends on the market price set by the manufacturer. Westphal believes that Ferring Pharmaceuticals plans to market Bravelle as a less expensive product than comparable recombinant agents.

Perhaps the pharmacist's most important role in infertility treatment is to provide patients with emotional support. Said Memoli, "In addition to dispensing the drug and providing counseling about how to use it, the pharmacist also has to be a friend to the patient and provide a shoulder to lean on.

"Fertility treatment is a tremendous emotional and financial burden," he continued. "I know people who have put off buying a house or taking a vacation to pay for it. Your life stops because you want to have a child."

Charlotte LoBuono

TIPS TO REMEMBER: Bravelle

  • OTC drugs and supplements, particularly blue or black cohosh, can compromise the efficacy of Bravelle and other fertility drugs. Pharmacists should ask patients if they are taking any OTC drugs or supplements.

  • Pain at the injection site and emotional irritability are the main side effects of treatment with Bravelle. Other adverse effects can include injection site pain (particularly if administered IM), lower abdominal tenderness, fluid retention in the ankles and legs, and some breast discomfort.

  • Patients may prefer the SC route of administration because it is less painful and more convenient.

  • Monitoring required during therapy includes measurement of LH in the urine, daily measurement of estrogen and progesterone, and regular ultrasound imaging to evaluate follicle development.

 

Charlotte LoBuono. New injection approved to treat infertility. Drug Topics 2002;11:16.