Pamidronate

Pamidronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body.

Pamidronate is used to treat high levels of calcium in the blood related to cancer (also called hypercalcemia of malignancy). Pamidronate is also used to treat Paget's disease of bone.

Pamidronate is used to treat bone damage caused by certain types of cancer such as breast cancer or bone marrow cancer. Pamidronate does not treat cancer. Use all other medications your doctor has prescribed for those conditions.

Pamidronate may also be used for purposes not listed in this medication guide.

Do not use pamidronate if you are pregnant. It could harm the unborn baby.

You should not use this medication if you are allergic to pamidronate or to other bisphosphonates such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa).

Before using pamidronate, tell your doctor if you have kidney disease, a history of thyroid surgery, or low levels of platelets or red blood cells.

Some people using medicines similar to pamidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Pamidronate can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using pamidronate, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Serious side effects of pamidronate include high fever, severe bone pain, severe joint or muscle pain, urinating less than usual or not at all, swelling, rapid weight gain, eye pain, vision changes, confusion, uneven heart rate, extreme thirst, muscle weakness or limp feeling, or seizure.

You should not use this medication if you are allergic to pamidronate or to other bisphosphonates such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa).

To make sure you can safely use pamidronate, tell your doctor if you have any of these other conditions:

• kidney disease;
• a history of thyroid surgery; or
• low levels of platelets or red blood cells.

Some people using medicines similar to pamidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category D. Do not use pamidronate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether pamidronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pamidronate.

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

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

• high fever;
• severe joint, bone, or muscle pain;
• new or unusual pain in your thigh or hip;
• urinating less than usual or not at all;
• swelling, rapid weight gain;
• pain or burning when you urinate;
• seizure (convulsions);
• eye pain, vision changes;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling, or jerking muscle movements.

Less serious side effects may include:

• low fever;
• stomach pain, loss of appetite, nausea, vomiting;
• constipation; or
• pain, redness, swelling or a hard painful lump under your skin around the IV needle.

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.

Contraindications

Pregnancy

Hypersensitivity

Cautions

Associated with renal toxicity, including potential renal failure (do not exceed single dose of 90 mg)

Severe renal impairment, musculoskeletal pain

Electrolyte abnormalities and myelosuppression may occur

Increased risk of osteonecrosis of the jaw (advise patients against dental work during IV bisphosphonate treatment)

Atypical subtrochanteric and diaphyseal femoral fractures reported with bisphosphonates; may present as thigh/groin pain in absence of trauma

May cause fetal harm when administered to pregnant women; bisphosphonates are incorporated into the bone matrix and gradually released over periods of weeks to years

Pamidronate is a prescription medication approved for the treatment of high blood levels of calcium that may be caused by certain types of cancer and Paget's disease. It is also approved to prevent or delay bone damage caused by multiple myeloma or breast cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pamidronate may be found in some form under the following brand names:

• Aredia

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that affect the kidneys including:
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve),
  • certain diuretics ("water pills"),
  • thalidomide (Thalomid),
  • vancomycin (Vancocin),
  • cancer chemotherapy medications,
  • certain antibiotics
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)

This is not a complete list of pamidronate drug interactions. Ask your doctor or pharmacist for more information.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of low thyroid levels like hard stools (constipation); not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad bone, joint, or muscle pain.
• Any new or strange groin, hip, or thigh pain.
• Fever.
• Feeling very tired or weak.
• Shortness of breath.
• Swelling.

Pamidronate Disodium is a sterile bone-resorption inhibitor available in 30 mg, 60 mg, or 90 mg vials for intravenous administration. The Pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains: 3 mg Pamidronate Disodium; 47 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. Each mL of the 60 mg vial contains: 6 mg Pamidronate Disodium; 40 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. Each mL of the 90 mg vial contains: 9 mg Pamidronate Disodium; 37.5 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. The pH of a 1% solution of Pamidronate disodium in distilled water is approximately 8.3. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-,disodium salt, and its structural formula is:

Pamidronate disodium is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form).

Inactive Ingredients. Mannitol, USP, Phosphoric Acid and/or Sodium Hydroxide, as necessary (for adjustment to pH range of 6.0 - 7.0) and Water for Injection, USP.

Vials – 3 mg/mL, 10 mL vial - each contains 30 mg of Pamidronate Disodium and 470 mg of Mannitol, USP in 10 mL Water for Injection, USP.
     Carton of 1 vial. NDC 61703-324-18.

Vials – 6 mg/mL, 10 mL vial - each contains 60 mg of Pamidronate Disodium and 400 mg of Mannitol, USP in 10 mL Water for Injection, USP.
     Carton of 1 vial. NDC 61703-325-18.

Vials – 9 mg/mL, 10 mL vial - each contains 90 mg of Pamidronate Disodium and 375 mg of Mannitol, USP in 10 mL Water for Injection, USP.
     Carton of 1 vial. NDC 61703-326-18.

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

                                                                                        434296

Hospira, Inc.
Lake Forest, IL 60045 USA

Product of Australia

Revised: 1/2014

10 mL Vial
NDC 61703-326-18
Sterile

Pamidronate Disodium
Injection

90 mg/ 10 mL
(9 mg/mL)

Rx only

Do not mix with calcium containing infusion solutions

For Intravenous Infusion

Refer to adult dosing. Begin at lower end of adult dosing range.

Multiple myeloma or metastatic bone lesions from solid tumors or Paget’s disease: Take adequate daily calcium and vitamin D supplement (if patient is not hypercalcemic).

Administration advice:
-For IV infusion administration only.
-Should not be mixed with calcium-containing infusion solutions.
-Administer as a single intravenous solution and infuse using an intravenous line for this drug alone.
-Visual inspection for particulate matter and discoloration prior to administration is recommended.

Storage requirements: The manufacturer product information should be consulted.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

Limitations of Use:
The safety and efficacy of this drug in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

Monitoring: Serum levels of calcium, phosphate, magnesium, and potassium, following initiation of therapy

Patient advice:
-Report any thigh, hip, or groin pain; these symptoms should be evaluated for an incomplete femur fracture.
-Avoid invasive dental procedures, if possible; maintain good dental hygiene and routine dental care.