Myochrysine

Gold sodium thiomalate is a form of gold that affects the process of inflammation in the body.

Gold sodium thiomalate is used to treat rheumatoid arthritis in adults and children.

Gold sodium thiomalate may also be used for purposes not listed in this medication guide.

You should not receive this medication if you have ever had an allergic reaction to a gold medication, if you have lupus, if you are severely debilitated, or if you are also using penicillamine (Cuprimine, Depen).

Before you receive gold sodium thiomalate, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, diabetes, inflammatory bowel disease, skin rash, lung disease, a history of bone marrow depression or blood problems, or if you are taking an anti-malaria medication.

Your doctor will perform blood or urine tests to make sure you do not have other conditions that would prevent you from safely receiving gold sodium thiomalate.

Tell your doctor about all other medicines you use, especially, chemotherapy, anti-malaria medicine, or heart or blood pressure medication.

You should not breast-feed while you are using this medication.

Call your doctor at once if you have a serious side effect such as unusual bleeding or bruising, skin rash or itching, peeling skin, hair loss, mouth pain, swollen tongue, severe or ongoing diarrhea, or flushing (warmth, redness, or tingly feeling).

You should not use this medication if you have ever had an allergic reaction to a gold medication, or if you have:

• lupus;
• if you are severely debilitated; or
• if you are also using penicillamine (Cuprimine, Depen).

To make sure gold sodium thiomalate is safe for you, tell your doctor if you have any of these conditions:

• kidney disease;
• liver disease;
• heart disease, high blood pressure, congestive heart failure;
• circulation problems or a history of stroke;
• cancer;
• diabetes;
• malaria;
• a blood cell disorder such as anemia or low levels of platelets in your blood; or
• a history of allergic reaction or blood cell problems caused by any medication.

FDA pregnancy category C. It is not known whether gold sodium thiomalate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Gold sodium thiomalate passes into breast milk and may affect a nursing infant. Gold sodium thiomalate is not recommended for use during breast-feeding. Do not take gold sodium thiomalate without first talking to your doctor if you are breast-feeding a baby.

You should not receive this medication if you have ever had an allergic reaction to a gold medication, if you have lupus, if you are severely debilitated, or if you are also using penicillamine (Cuprimine, Depen).

Before you receive gold sodium thiomalate, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, diabetes, inflammatory bowel disease, skin rash, lung disease, a history of bone marrow depression or blood problems, or if you are taking an anti-malaria medication.

Your doctor will perform blood or urine tests to make sure you do not have other conditions that would prevent you from safely receiving gold sodium thiomalate.

Tell your doctor about all other medicines you use, especially, chemotherapy, anti-malaria medicine, or heart or blood pressure medication.

You should not breast-feed while you are using this medication.

Call your doctor at once if you have a serious side effect such as unusual bleeding or bruising, skin rash or itching, peeling skin, hair loss, mouth pain, swollen tongue, severe or ongoing diarrhea, or flushing (warmth, redness, or tingly feeling).

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)

• It is used to treat rheumatoid arthritis.
• It may be given to you for other reasons. Talk with the doctor.

Use Myochrysine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Myochrysine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Myochrysine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Rx only

Physicians planning to use Gold Sodium Thiomalate should thoroughly familiarize themselves with its toxicity and its benefits. The possibility of toxic reactions should always be explained to the patient before starting therapy. Patients should be warned to report promptly any symptoms suggesting toxicity. Before each injection of Gold Sodium Thiomalate, the physician should review the results of laboratory work, and see the patient to determine the presence or absence of adverse reactions since some of these can be severe or even fatal.

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/mm3, eosinophilia above 5 percent, platelet decrease below 100,000/mm3, albuminuria, hematuria, pruritus, skin eruption, stomatitis, or persistent diarrhea. No additional injections of Gold Sodium Thiomalate 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 Gold Sodium Thiomalate 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 Gold Sodium Thiomalate at high dose levels (2 mg/kg weekly for 45 weeks, followed by 6mg/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 Gold Sodium Thiomalate.

Pregnancy

Gold Sodium Thiomalate 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 Gold Sodium Thiomalate 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 Gold Sodium Thiomalate 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. Gold Sodium Thiomalate 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 Gold Sodium Thiomalate, 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.