"The US Food and Drug Administration (FDA) has approved tofacitinib citrate extended-release (Xeljanz XR, Pfizer Inc) 11-mg tablets for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have not responde"...
Gold Sodium Thiomalate is indicated in the treatment of selected cases of active rheumatoid arthritis—both adult and juvenile type. The greatest benefit occurs in the early active stage. In late stages of the illness when cartilage and bone damage have occurred, gold can only check the progression of rheumatoid arthritis and prevent further structural damage to joints. It cannot repair damage caused by previously active disease.
Gold Sodium Thiomalate should be used only as one part of a complete program of therapy; alone it is not a complete treatment.
DOSAGE AND ADMINISTRATION
Gold Sodium Thiomalate should be administered only by intramuscular injection, preferably intragluteally. It should be given with the patient lying down. He should remain recumbent for approximately 10 minutes after the injection.
Therapeutic effects from Gold Sodium Thiomalate occur slowly. Early improvement, often limited to a reduction in morning stiffness, may begin after six to eight weeks of treatment, but beneficial effects may not be observed until after months of therapy.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if material has darkened. Color should not exceed pale yellow.
For the adult of average size the following dosage schedule is suggested:
1st injection............................................................. 10 mg
2nd injection........................................................... 25 mg
3rd and subsequent injections, 25 to 50 mg until there is toxicity or major clinical improvement, or, in the absence of either of these, the cumulative dose of Gold Sodium Thiomalate reaches one gram.
Gold Sodium Thiomalate is continued until the cumulative dose reaches one gram unless toxicity or major clinical improvement occurs. If significant clinical improvement occurs before a cumulative dose of one gram has been administered, the dose may be decreased or the interval between injections increased as with maintenance therapy. Maintenance doses of 25 to 50 mg every other week for two to 20 weeks are recommended. If the clinical course remains stable, injections of 25 to 50 mg may be given every third and subsequently every fourth week indefinitely. Some patients may require maintenance treatment at intervals of one to three weeks. Should the arthritis exacerbate during maintenance therapy, weekly injections may be resumed temporarily until disease activity is suppressed. Should a patient fail to improve during initial therapy (cumulative dose of one gram), several options are available.
- the patient may be considered to be unresponsive and Gold Sodium Thiomalate is discontinued.
- the same dose (25 to 50 mg) of Gold Sodium Thiomalate may be continued for approximately ten additional weeks.
- the dose of Gold Sodium Thiomalate may be increased by increments of 10 mg every one to four weeks, not to exceed 100 mg in single injection.
If significant clinical improvement occurs using option 2 or 3, the maintenance schedule described above should be initiated. If there is no significant improvement or if toxicity occurs, therapy with Gold Sodium Thiomalate should be stopped. The higher the individual dose of Gold Sodium Thiomalate, the greater the risk of gold toxicity. Selection of one of these options for chrysotherapy should be based upon a number of factors, including the physician's experience with gold salt therapy, the course of the patient's condition, the choice of alternative treatments, and the availability of the patient for the close supervision required.
Juvenile Rheumatoid Arthritis
The pediatric dose of Gold Sodium Thiomalate is proportional to the adult dose on a weight basis. After the initial test dose of 10 mg, the recommended dose for children is one mg per kilogram body weight, not to exceed 50 mg for a single injection. Otherwise, the guidelines given above for administration to adults also apply to children.
Concomitant Drug Therapy—Gold salts should not be used concomitantly with penicillamine.
The safety of coadministration with cytotoxic drugs has not been established. Other measures, such as salicylates, other nonsteroidal anti-inflammatory drugs, or systemic corticosteroids, may be continued when Gold Sodium Thiomalate is initiated. After improvement commences, analgesic and anti-inflammatory drugs may be discontinued slowly as symptoms permit.
Injection Gold Sodium Thiomalate is a light yellow to yellow solution, depending on potency, which must be protected from light. It is supplied as follows:
NDC 11098-533-01 Gold Sodium Thiomalate, 50 mg per
mL, 1 mL in 2 mL (partially filled) vials in packages of 6.
NDC 11098-533-10 Gold Sodium Thiomalate, 50 mg per mL, 10 mL vials.
STORAGE: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Store container in carton until contents have been used.
Taylor Pharmaceuticals, Decatur, IL 62522. Rev. 03/06. FDA revision date: n/aThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/25/2008
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