Before treatment is started, the patient's hemoglobin, erythrocyte, white blood cell, differential and platelet counts should be determined, and urinalysis should be done to serve as basic reference. Urine should be analyzed for protein and sediment changes prior to each injection. Complete blood counts including platelet estimation should be made before every second injection throughout treatment. The occurrence of purpura or ecchymoses at any time always requires a platelet count.

Danger signals of possible gold toxicity include: rapid reduction of hemoglobin, leukopenia below 4000 WBC/mm ³ , eosinophilia above 5 percent, platelet decrease below 100,000/mm ³ , albuminuria, hematuria, pruritus, skin eruption, stomatitis, or persistent diarrhea. No additional injections of MYOCHRYSINE should be given unless further studies show these abnormalities to be caused by conditions other than gold toxicity.

General

Gold salts should not be used concomitantly with penicillamine.

The safety of coadministration with cytotoxic drugs has not been established.

Caution is indicated in the use of MYOCHRYSINE in patients with the following:

1. a history of blood dyscrasias such as granulocytopenia or anemia caused by drug sensitivity,
2. allergy or hypersensitivity to medications,
3. skin rash,
4. previous kidney or liver disease,
5. marked hypertension,
6. compromised cerebral or cardiovascular circulation.

Diabetes mellitus or congestive heart failure should be under control before gold therapy is instituted.

Carcinogenicity

Renal adenomas have been reported in long-term toxicity studies of rats receiving MYOCHRYSINE at high dose levels (2 mg/kg weekly for 45 weeks, followed by 6 mg/kg daily for 47 weeks), approximately 2 to 42 times the usual human dose. These adenomas are histologically similar to those produced in rats by chronic administration of experimental gold compounds and other heavy metals, such as lead. No reports have been received of renal adenomas in man in association with the use of MYOCHRYSINE.

Pregnancy

Pregnancy Category C.

MYOCHRYSINE has been shown to be teratogenic during the organogenetic period in rats and rabbits when given in doses, respectively, of 140 and 175 times the usual human dose. Hydrocephaly and microphthalmia were the malformations observed in rats when MYOCHRYSINE was administered subcutaneously at a dose of 25 mg/kg/day from day 6 through day 15 of gestation. In rabbits, limb malformations and gastroschisis were the malformations observed when MYOCHRYSINE was administered subcutaneously at doses of 20-45 mg/kg/day from day 6 through day 18 of gestation.

There are no adequate and well-controlled studies in pregnant women. MYOCHRYSINE should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers

The presence of gold has been demonstrated in the milk of lactating mothers. In addition, gold has been found in the serum and red blood cells of a nursing infant. In view of the above findings and because of the potential for serious adverse reactions in nursing infants from MYOCHRYSINE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The slow excretion and persistence of gold in the mother, even after therapy is discontinued, must also be kept in mind.

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