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Myochrysine

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Myochrysine

Myochrysine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Myochrysine (gold sodium thiomalate) is used as an injection to treat adult and juvenile rheumatoid arthritis. It is a form of gold. Gold suppresses the inflammatory process. Common side effects include flushing, dizziness, headache, nausea, vomiting, weakness, and sweating soon after the injection. Increased joint pain may occur 1-2 days after injection.

For the adult of average size the following dosage schedule for Myochrysine is suggested: Weekly Injections: 1st injection, 10 mg; 2nd injection, 25 mg; 3rd and subsequent injections, 25 to 50 mg until there is toxicity or major clinical improvement. Myochrysine may interact with other medications. Tell your doctor all medications and supplements you use. During pregnancy, Myochrysine should be used only when prescribed. If you become pregnant or think you may be pregnant, inform your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Myochrysine (gold sodium thiomalate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Myochrysine in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, sweating, vomiting; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • skin rash, bruising, severe tingling, numbness, muscle weakness, burning pain in your hands or feet;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • itching or peeling of skin, hair loss, or problems with your fingernails or toenails;
  • white patches or sores inside your mouth or on your lips;
  • mouth pain, swollen tongue;
  • severe or ongoing diarrhea;
  • slow heart rate;
  • eye pain or vision problems;
  • flushing (warmth, redness, or tingly feeling);
  • feeling like you might pass out;
  • puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy;
  • blood in your urine or stools;
  • chest pain, dry cough, wheezing, feeling short of breath;
  • nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • confusion, hallucinations, or seizure.

Other common side effects may include:

  • mild headache or dizziness;
  • mild diarrhea, stomach cramps;
  • joint pain; or
  • a metallic taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Myochrysine (Gold Sodium Thiomalate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Myochrysine FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 Gold Sodium Thiomalate administered is between 400 and 800mg. 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 Gold Sodium Thiomalate 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 Gold Sodium Thiomalate 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-Barré 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 Gold Sodium Thiomalate; this reaction usually subsides after the first few injections.

Management Of Adverse Reactions

Treatment with Gold Sodium Thiomalate 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 Gold Sodium Thiomalate. 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.

Gold Sodium Thiomalate should not be reinstituted after severe or idiosyncratic reactions.

Gold Sodium Thiomalate may be readministered following resolution of mild reactions, using a reduced dosage schedule. If an initial test dose of 5 mg Gold Sodium Thiomalate 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.

Read the entire FDA prescribing information for Myochrysine (Gold Sodium Thiomalate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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