Solganal

Generic Name: gold compound (Oral route, Parenteral route)

Commonly used brand name(s):

In the U.S.

• Ridaura

Available Dosage Forms:

• Capsule

Uses For Solganal

The gold compounds are used in the treatment of rheumatoid arthritis. They may also be used for other conditions as determined by your doctor.

In addition to the helpful effects of this medicine in treating your medical problem, it has side effects that can be very serious. Before you take this medicine, you should discuss with your doctor the good that this medicine will do as well as the risks of using it.

Auranofin is available only with your doctor's prescription. The other gold compounds are given by your health care professional.

Schering-Plough discontinued aurothioglucose in May 2002.

Before Using Solganal

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Auranofin has been tested only in adult patients and there is no specific information about its use in children. However, gold sodium thiomalate have been tested in children and have not been shown to cause different side effects or problems than they do in adults.

Geriatric

These medicines have been tested and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Studies on birth defects with gold compounds have not been done in humans. However, studies in animals have shown that gold compounds may cause birth defects.

Breast Feeding

Gold sodium thiomalate pass into the breast milk and may cause unwanted effects in nursing babies. It is not known whether auranofin passes into the breast milk.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Artemether
• Chloroquine
• Halofantrine
• Hydroxychloroquine
• Mefloquine
• Penicillamine
• Primaquine
• Proguanil
• Pyrimethamine
• Quinacrine
• Quinidine
• Quinine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Penicillamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or blood vessel disease or
• Colitis or
• Kidney disease (or history of) or
• Lupus erythematosus or
• Sjögren's syndrome or
• Skin disease—The chance of unwanted effects may be increased.

Proper Use of gold compound

This section provides information on the proper use of a number of products that contain gold compound. It may not be specific to Solganal. Please read with care.

In order for this medicine to work, it must be taken regularly as ordered by your doctor. Continue receiving the injections or taking auranofin even if you think the medicine is not working. You may not notice the effects of this medicine until after three to six months of regular use.

For patients taking auranofin:

• Do not take more of this medicine than ordered by your doctor. Taking too much auranofin may increase the chance of serious unwanted effects.

If you have any questions about this, check with your doctor.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For auranofin
• For oral dosage form (capsules):
  • For arthritis:
    • Adults—6 milligrams (mg) once a day or 3 mg twice a day. After six months, your doctor may increase the dose to 3 mg three times a day.
    • Children—Dose must be determined by your doctor.
• For injection dosage form:
  • For arthritis:
    • Adults and teenagers—10 milligrams (mg) for the first dose, then 25 mg once a week for the next two weeks, then 25 or 50 mg once a week. The medicine is injected into a muscle. After several months, the injections may be given less often (25 or 50 mg every two weeks for a while, then every three or four weeks).
    • Children 6 to 12 years of age—2.5 mg for the first dose, then 6.25 mg once a week for the next two weeks, then 12.5 mg once a week. The medicine is injected into a muscle. After several months, the injections may be given less often (6.25 or 12.5 mg every three or four weeks).
    • Children younger than 6 years of age—Dose must be determined by your doctor.

• For gold sodium thiomalate
• For injection dosage form:
  • For arthritis:
    • Adults and teenagers—10 milligrams (mg) for the first dose, then 25 mg a week later, then 25 or 50 mg once a week. The medicine is injected into a muscle. After several months, the injections may be given less often (25 or 50 mg every two weeks for a while, then every three or four weeks).
    • Children—10 mg for the first dose, then 1 mg per kilogram (about 0.45 mg per pound) of body weight, but not more than a total of 50 mg, once a week. The medicine is injected into a muscle. After several months, the same dose may be given less often (every two weeks for a while, then every three or four weeks).

Missed Dose

Call your doctor or pharmacist for instructions.

For patients taking auranofin: If you miss a dose of this medicine, and your dosing schedule is—

• One dose a day—Take the missed dose as soon as possible. However, if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—Take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Solganal

Gold compounds may cause some people to become more sensitive to sunlight than they are normally. These people may break out in a rash after being in the sun, or a skin rash that is already present may become worse. To protect yourself, it is best to:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing.
• Ask your doctor if you may apply a sun block product. Products that have a skin protection factor (SPF) of at least 15 work best, but some patients may require a product with a higher SPF number, especially if they have a fair complexion.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

For patients taking auranofin:

• Your doctor should check your progress at regular visits. Blood and urine tests may be needed to make certain that this medicine is not causing unwanted effects.

For patients receiving gold injections:

• Immediately following an injection of this medicine, side effects such as dizziness, feeling faint, flushing or redness of the face, nausea or vomiting, increased sweating, or unusual weakness may occur. These will usually go away after you lie down for a few minutes. If any of these effects continue or become worse, or if you notice any other effects within 10 minutes or so after receiving an injection, tell your health care professional right away.
• Joint pain may occur for 1 or 2 days after you receive an injection of this medicine. This effect usually disappears after the first few injections. However, if this continues or is bothersome, check with your doctor.

Solganal Side Effects

Gold compounds have been shown to cause tumors and cancer of the kidney when given to animals in large amounts for a long time. However, these effects have not been reported in humans receiving gold compounds for arthritis. If you have any questions about this, check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Irritation or soreness of tongue—less common with auranofin
• metallic taste—less common with auranofin
• redness, soreness, swelling, or bleeding of gums—rare with auranofin
• skin rash or itching
• ulcers, sores, or white spots on lips or in mouth or throat

• Bloody or cloudy urine
• hives

• Abdominal or stomach pain, cramping, or burning (severe)
• bloody or black, tarry stools
• confusion
• convulsions (seizures)
• coughing, hoarseness, difficulty in breathing, shortness of breath, tightness in chest, or wheezing
• dark urine
• decreased urination
• decreased vision
• difficulty in swallowing
• feeling of something in the eye
• fever
• hair loss
• hallucinations (hearing, seeing, or feeling things that are not there)
• irritation of nose, throat, or upper chest area, possibly with hoarseness or coughing
• irritation of vagina
• nausea, vomiting, or heartburn (severe and/or continuing)
• numbness, tingling, pain, or weakness, especially in the face, hands, arms, or feet
• pale stools
• painful or difficult urination
• pain in lower back, side, or lower abdomen (stomach) area
• pain, redness, itching, or tearing of eyes
• pinpoint red spots on skin
• problems with muscle coordination
• red, thickened, or scaly skin
• sore throat and fever with or without chills
• swelling of face, fingers, ankles, lower legs, or feet
• swellings (large) on face, eyelids, mouth, lips, and/or tongue
• swollen and/or painful glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps or pain (mild or moderate)
• bloated feeling, gas, or indigestion (mild or moderate)
• decrease or loss of appetite
• diarrhea or loose stools
• nausea or vomiting (mild or moderate)

• Constipation—with auranofin
• joint pain—with

Some patients receiving auranofin have noticed changes in the taste of certain foods. If you notice a metallic taste while receiving any gold compound, check with your doctor as soon as possible. If you notice any other taste changes while you are taking auranofin, it is not necessary to check with your doctor unless you find this effect especially bothersome.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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