Gallium Nitrate

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

Tell your caregivers right away if you have:

• severe or ongoing nausea or vomiting;
• pale skin, easy bruising or bleeding;
• blurred vision, headache or pain behind your eyes;
• confusion, hallucinations;
• cough, noisy breathing, feeling short of breath; or
• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

• nausea, vomiting, diarrhea, constipation;
• weakness, fever or cold feeling;
• swelling in your ankles or feet;
• fast heart rate; or
• numbness or tingling, skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Gallium nitrate can harm your kidneys. This effect is increased when you also use certain other medicines, including:

• antivirals;
• chemotherapy;
• injected antibiotics;
• medicine for bowel disorders;
• medicine to prevent organ transplant rejection;
• injectable osteoporosis medication; or
• some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

If you need to use any of the medicines above, you may need to stop using gallium nitrate and drink plenty of fluids for several days.

This list is not complete. Other drugs may interact with gallium nitrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with gallium nitrate. Not all possible interactions are listed in this medication guide.

General

Hypercalcemia

• Prior to initiating therapy, establish adequate hydration and urinary output in order to increase renal excretion of calcium.1 2

• Maintain adequate hydration throughout therapy.1

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by slow IV infusion.1

Dilute calculated daily dose, preferably in 1 L of 0.9% sodium chloride injection or 5% dextrose injection.1 Discard unused portion of vial.1

Administer by slow IV infusion over 24 hours.1

Dosage

Adults

200 mg/m2 daily for 5 consecutive days.1 4

If used for mild hypercalcemia and few associated symptoms, 100 mg/m2 daily for 5 days may be used.1

If optimum serum calcium concentrations are achieved in <5 days, therapy may be discontinued early.1

Prescribing Limits

Adults

Safety and efficacy of repeated courses not established.1

Special Populations

Renal Impairment

Contraindicated in patients with severe renal impairment (Scr >2.5 mg/dL).1

Caution if used in patients with mild to moderate renal impairment (Scr 2–2.5 mg/dL); manufacturer makes no specific recommendations regarding dosage in these patients.1 (See Renal Impairment under Cautions.)

• Exerts hypocalcemic effect by inhibiting calcium resorption from bone, possibly by reducing increased bone turnover. 1

• No cytotoxic effects were seen on bone cells of animals treated with gallium.1