A variety of adverse reactions may develop during the initial phase (weekly injections) of therapy or during maintenance treatment. Adverse reactions are observed most frequently when the cumulative dose of MYOCHRYSINE administered is between 400 and 800 mg. Very uncommonly, complications occur days to months after cessation of treatment.

Cutaneous reactions: Dermatitis is the most common reaction. Any eruption, especially if pruritic, that develops during treatment with MYOCHRYSINE should be considered a reaction to gold until proven otherwise. Pruritus often exists before dermatitis becomes apparent, and therefore should be considered a warning signal of impending cutaneous reaction. The most serious form of cutaneous reaction is generalized exfoliative dermatitis which may lead to alopecia and shedding of nails. Gold dermatitis may be aggravated by exposure to sunlight or an actinic rash may develop.

Mucous membrane reactions: Stomatitis is the second most common adverse reaction. Shallow ulcers on the buccal membranes, on the borders of the tongue, and on the palate or in the pharynx may occur as the only adverse reaction, or along with dermatitis. Sometimes diffuse glossitis or gingivitis develops. A metallic taste may precede these oral mucous membrane reactions and should be considered a warning signal.

Conjunctivitis is a rare reaction.

Renal reactions: Gold may be toxic to the kidney and produce a nephrotic syndrome or glomerulitis with hematuria. These renal reactions are usually relatively mild and subside completely if recognized early and treatment is discontinued. They may become severe and chronic if treatment is continued after onset of the reaction. Therefore, it is important to perform a urinalysis before every injection, and to discontinue treatment promptly if proteinuria or hematuria develops.

Hematologic reactions: Blood dyscrasia due to gold toxicity is rare, but because of the potential serious consequences it must be constantly watched for and recognized early by frequent blood examinations done throughout treatment. Granulocytopenia; thrombocytopenia, with or without purpura; hypoplastic and aplastic anemia; and eosinophilia have all been reported. These hematologic disorders may occur separately or in combinations.

Nitritoid and allergic reactions: Reactions of the "nitritoid type" which may resemble anaphylactoid effects have been reported. Flushing, fainting, dizziness and sweating are most frequently reported. Other symptoms that may occur include: nausea, vomiting, malaise, headache, and weakness.

More severe, but less common effects include: anaphylactic shock, syncope, bradycardia, thickening of the tongue, difficulty in swallowing and breathing, and angioneurotic edema. These effects may occur almost immediately after injection or as late as 10 minutes following injection. They may occur at any time during the course of therapy and if observed, treatment with MYOCHRYSINE should be discontinued.

Miscellaneous reactions: Gastrointestinal reactions have been reported, including nausea, vomiting, anorexia, abdominal cramps and diarrhea. Ulcerative enterocolitis, which can be severe or even fatal, has been reported rarely.

There have been rare reports of reactions involving the eye such as iritis, corneal ulcers, and gold deposits in ocular tissues. Peripheral and central nervous system complications have been reported rarely. Peripheral neuropathy, with or without fasciculations, sensorimotor effects (including Guillain-Barrγ© syndrome) and elevated spinal fluid protein have been reported. Central nervous system complications have included confusion, hallucinations and seizures. Usually these signs and symptoms cleared upon discontinuation of gold therapy.

Hepatitis, jaundice, with or without cholestasis, gold bronchitis, pulmonary injury manifested by interstitial pneumonitis and fibrosis, partial or complete hair loss and fever have also been reported.

Sometimes arthralgia occurs for a day or two after an injection of MYOCHRYSINE; this reaction usually subsides after the first few injections.

MANAGEMENT OF

SIDE EFFECTS

Treatment with MYOCHRYSINE should be discontinued immediately when toxic reactions occur. Minor complications such as localized dermatitis, mild stomatitis, or slight proteinuria generally require no other therapy and resolve spontaneously with suspension of MYOCHRYSINE. Moderately severe skin and mucous membrane reactions often benefit from topical corticosteroids, oral antihistaminics, and soothing or anesthetic lotions.

If stomatitis or dermatitis becomes severe or more generalized, systemic corticosteroids (generally, prednisone 10 to 40 mg daily in divided doses) may provide symptomatic relief.

For serious renal, hematologic, pulmonary, and enterocolitic complications, high doses of systemic corticosteroids (prednisone 40 to 100 mg daily in divided doses) are recommended. The optimum duration of corticosteroid treatment varies with the response of the individual patient. Therapy may be required for many months when adverse effects are unusually severe or progressive.

In patients whose complications do not improve with high-dose corticosteroid treatment, or who develop significant steroid-related adverse reactions, a chelating agent may be given to enhance gold excretion. Dimercaprol (BAL) has been used successfully, but patients must be monitored carefully as numerous untoward reactions may attend its use. Corticosteroids and a chelating agent may be used concomitantly.

MYOCHRYSINE should not be reinstituted after severe or idiosyncratic reactions.

MYOCHRYSINE may be readministered following resolution of mild reactions, using a reduced dosage schedule. If an initial test dose of 5 mg MYOCHRYSINE is well-tolerated, progressively larger doses (5 to 10 mg increments) may be given at weekly to monthly intervals until a dose of 25 to 50 mg is reached.

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