Parlodel® (bromocriptine mesylate) capsules will be available shortly

WHAT IS PARLODEL® (BROMOCRIPTINE MESYLATE)?

Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity.

WHAT CONDITIONS ARE TREATED WITH PARLODEL?1

Parlodel can be used for a variety of different conditions.

1. Prevention/Suppression of Breast Milk/Lack of Menstrual Periods

Parlodel is used to treat symptoms of hyperprolactemia (high levels of a natural substance called prolactin in the body), which can be associated with lack of menstrual periods, unwanted breast milk including, an overabundance of breast milk discharged from the nipples, and infertility. If breast milk production has already begun, your doctor can advise you about other methods of stopping lactation.

2. Treatment of high levels of the hormone prolactin

Parlodel treatment is used in patients with prolactin-secreting adenomas (tumors that secrete prolactin), as it has been shown to reduce tumor size. In cases where adenectomy is to be performed, a course of Parlodel therapy may be used to reduce tumor mass prior to surgery.

3. Treatment of Acromegaly

Parlodel is used to treat acromegaly (abnormal growth of the bones including: hands, feet, and face). It is caused when your pituitary gland produces too much growth hormone. In some instances, Parlodel is used alone or as an adjunctive therapy with pituitary irradiation or surgery. Since the effect of pituitary radiation may not become maximal for several years, adjunctive therapy with Parlodel may provide a benefit before the effects of irradiation are seen.

4. Treatment of Parkinson’s Disease

Parlodel is used alone or with other medications to treat Parkinson’s disease. It can improve your ability to move as well as decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. Parlodel may be used as an adjunctive treatment to levodopa and may provide additional therapeutic benefits in patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (i.e., develop a tolerance) to levodopa therapy, and those who are experiencing “end of dose failure” on levadopa therapy. Use of Parlodel may permit a reduction of the maintenance dose of levodopa and as such, may reduce the adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements and the marked swings in motor function. Continued efficacy of Parlodel during treatment of more than two years has not been established.

Data are insufficient to evaluate the potential benefit from treating newly diagnosed Parkinson’s disease with Parlodel; however, studies have shown that significantly more adverse reactions arise from patients treated with Parlodel than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.

1. Parlodel. Full Prescribing Information

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

THIS PACKAGE INSERT IS FOR USE WITH PARLODEL® (BROMOCRIPTINE MESYLATE) ONLY

CONTRAINDICATIONS

You should not use Parlodel® (bromocriptine mesylate) if you are hypersensitive to bromocriptine or to any of the other ingredients in Parlodel, have uncontrolled hypertension (high blood pressure), if you are being treated for hyperprolactinemia (a condition of elevated levels of prolactin – the protein responsible for breast development during pregnancy and lactation), have sensitivity to any ergot alkaloids (chemicals produced by certain plant fungi).

Parlodel should be withdrawn when pregnancy is diagnosed.

In the event that you are pregnant and your doctor reinstitutes Parlodel therapy to control a rapidly expanding macroadenoma (pituitary tumors that are larger than ten millimeters in diameter), and you experience sudden high blood pressure, your doctor must weigh the benefit of continuing Parlodel against the possible risk of its use.

When Parlodel is being used to treat acromegaly – a disorder caused by excessive production of growth hormone that results in abnormal growth of bones including hands, feet, and face; or prolactemia, a condition charactertized by a deficiency of prolactin; or Parkinson’s disease, and you subsequently become pregnant, your doctor will make a decision as to whether the therapy continues to be medically necessary or should be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (eclampsia, preeclampsia, or pregnancy-induced hypertension) unless your doctor determines that withdrawal of Parlodel is considered to be medically unwise.

Parlodel should not be used during the postpartum period if you have a history of heart disease or other severe cardiovascular conditions unless your doctor determines that withdrawal is not medically indicated.

WARNINGS

Your doctor should conduct a complete evaluation of your pituitary gland before starting treatment with Parlodel.

The safety of Parlodel treatment during pregnancy to mother and fetus has not been established.

If you become pregnant while taking Parlodel, tell your doctor immediately. Your doctor should monitor you closely during pregnancy if you are taking Parlodel. Adenomas on the pituitary may expand and compress the optic nerve, which may require emergency pituitary surgery. In most cases, optic nerve compression resolves after delivery. Reinitiating Parlodel may improve vision if you have suffered from nerve compression during pregnancy.

Parlodel may cause extreme sleepiness, and episodes of sudden sleep onset, particularly if you have Parkinson’s disease. You should not drive or operate heavy machinery while taking Parlodel. If you experience extreme sleepiness or sudden sleep onset, your doctor may reduce your Parlodel dose or discontinue your Parlodel therapy.

Low blood pressure may also occur with Parlodel treatment for any indication; particular care should be exercised when driving a vehicle or operating machinery. In rare cases, high blood pressure, heart attack, seizures, and stroke have occurred in women who are taking Parlodel for the inhibition of lactation. Any of these reactions may occur, even in women who have had normal pregnancies and deliveries. If you develop a constant and/or progressively severe headache or visual disturbances, seek emergency help immediately.

Use of Parlodel for the prevention of lactation or if you have uncontrolled high blood pressure is not recommended. Parlodel therapy should be discontinued if you are being treated for hyperprolactinemia and become pregnant.

When you are undergoing Parlodel treatment for a rapidly expanding macroadenoma, and you experience severe high blood pressure associated with pregnancy, the benefit of continuing with Parlodel treatment must be weighed against the possibility of developing high blood pressure. Likewise, when Parlodel is being used to treat acromegaly or Parkinson’s disease and you subsequently become pregnant, the benefit of Parlodel therapy must be weighed against the possibly of high blood pressure. If you develop high blood pressure, Parlodel should be withdrawn unless your doctor decides that withdrawal would cause more harm than good.

Use of Parlodel with other ergot alkaloids is not advised. Similarly, use of Parlodel with medicines for high blood pressure is not advised.

Your blood pressure should be monitored if you are taking Parlodel. If high blood pressure, severe or unremitting headaches or other evidence of central nervous system problems arise, Parlodel therapy should be discontinued.

Long-term and high-dose treatment with Parlodel can cause fluid build-up, scarring, development of fibrous tissue, and inflammation of heart and lung tissue. If you have these symptoms, your doctor should examine you thoroughly, and discontinuation of Parlodel treatment should be considered.

PRECAUTIONS

Safety and efficacy of Parlodel have not been established in patients with kidney or liver disease. Parlodel should be used with caution in patients with a history of psychosis or cardiovascular disease. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption should not take Parlodel.

Hyperprolactemic States: Visual impairment can occur in patients having macroprolactemia. Parlodel treatment can reduce hyperprolactermia; however, there is a chance of visual impairment even with successful treatment. In these instances, your doctor should assess whether the Parlodel dosage should be reduced, even if there is some elevation of prolactin and tumor re-expansion.

Careful assessment of the pituitary is essential to detect the presence of a prolactin-secreting adenoma, especially when you are trying to become pregnant. If you are not seeking pregnancy, you should use contraceptive measures, other than oral contraceptives, during Parlodel treatment. Pregnancy testing is recommended every 4 weeks during Parlodel treatment. Parlodel treatment should be discontinued as soon as pregnancy is detected. If you have any symptoms of enlargement or a previously undetected or existing prolactin-secreting tumor, you should be monitored closely during pregnancy.

Acromegaly: Numb fingers and toes in response to cold is a side effect seen with some acromegalic patients treated with Parlodel. This condition can be reversed by reducing the dose of Parlodel and may be prevented by keeping the fingers warm. There is no evidence that Parlodel increases the incidence of peptic ulcers in acromegalic patients treated with Parlodel; however, some cases of severe gastrointestinal bleeding, sometimes fatal, have been reported.

Tumor expansion should be monitored during Parlodel treatment.

Parkinson’s Disease: Safety during long-term use for more than 2 years at the doses required for Parkinsonism has not been established.

You should be periodically monitored for liver, kidney, and cardiovascular function and should have regular blood tests.

Patients who are taking Parlodel at the same time as levedopa may have hallucinations that usually resolve when the Parlodel dosage is decreased; however, in some instances, Parlodel therapy may need to be discontinued.

Patients treated with anti-Parkinson’s medicines can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. You should discuss any of these urges with your doctor.

If you have any history of heart problems, speak with your doctor as you may need monitoring during your Parlodel treatment.

You should be monitored for melanomas on a regular basis when using Parlodel for any indication.

DRUG INTERACTIONS

Alcohol may potentiate the side effects of Parlodel. Parlodel may interact with dopamine antagonists, butyrophenones, and certain other agents. Caution should be used when administering Parlodel with drugs that are strong inhibitors of CYP3A4. Concomitant use of Parlodel with other ergot alkaloids is not recommended.

PREGNANCY

There have been no significant studies that show that Parlodel causes a risk to the fetus in any trimester.

Nursing Mothers: Parlodel should not be used during lactation in postpartum women.

PEDIATRIC USE

The safety and efficacy of Parlodel for the treatment of prolactin-secreting pituitary adenomas have been established in patients age 16 to adult. Safety and efficacy of Parlodel has not been established in pediatric patients under the age of 8 years. There are limited data supporting the use of Parlodel for the treatment of prolactin-secreting adenomas in patients aged 11-15.

GERIATRIC USE

There are no studies demonstrating that patients older than 65 repond to Parlodel differently than younger patients.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch