Reclast

DRUG DESCRIPTION

Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (l-Hydroxy-2-imidazol-l-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:

Reclast®
  (zoledronic acid) Structural Formula Illustration

Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2•H2O and a molar mass of 290.1 g/Mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the Reclast solution for infusion is approximately 6.0 - 7.0.

Reclast Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.

Inactive Ingredients: 4950 mg of mannitol, USP; and 30 mg of sodium citrate, USP.

What are the possible side effects of zoledronic acid (Reclast, Zometa)?

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 any of these serious side effects:

  • urinating less than usual or not at all;
  • muscle spasms, numb or tingly feeling (especially around your mouth);
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising, unusual weakness;
  • severe joint, bone, or muscle pain;...

Read All Potential Side Effects and See Pictures of Reclast »

What are the precautions when taking zoledronic acid injection (Reclast)?

Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates such as alendronate or risedronate; or if you have trouble breathing (wheezing) after taking aspirin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, low calcium levels in the blood, problem taking calcium/vitamin D supplements, recent or planned dental surgery (e.g., tooth removal), certain gut problems (malabsorption, surgery on the small intestine), treatment with zoledronic acid (e.g., for cancer), parathyroid/thyroid...

Read All Potential Precautions of Reclast »


Reclast Consumer (continued)

SIDE EFFECTS: Nausea, tiredness, flu-like symptoms (e.g., fever, chills, muscle/joint aches), dizziness, headache, or pain/redness/swelling at the injection site may occur. Most of these side effects are mild and occur within 3 days of treatment. Flu-like symptoms may be reduced by taking acetaminophen or ibuprofen after the treatment. If any of these effects worsen or last more than 4 days, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, jaw pain, unusual weakness, eye problems (e.g., redness/itching/swelling, sensitivity to light), muscle spasms, numb/tingling skin, sores in jaw/mouth, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates such as alendronate or risedronate; or if you have trouble breathing (wheezing) after taking aspirin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, low calcium levels in the blood, problem taking calcium/vitamin D supplements, recent or planned dental surgery (e.g., tooth removal), certain gut problems (malabsorption, surgery on the small intestine), treatment with zoledronic acid (e.g., for cancer), parathyroid/thyroid problems (e.g., hypoparathyroidism, thyroid/parathyroid surgery), severe loss of body water (dehydration).

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop using zoledronic acid before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause severe kidney problems, especially in the elderly. Consult your doctor or pharmacist for more information. To help prevent harm to your kidneys, drink plenty of fluids unless otherwise directed by your doctor. (See also How to Use section.)

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for information on reliable forms of birth control.

It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Reclast Patient Information Including Side Effects

Brand Names: Reclast, Zometa

Generic Name: zoledronic acid (Pronunciation: zole DRO nik AS sid)

  • What is zoledronic acid (Reclast)?
  • What are the possible side effects of zoledronic acid (Reclast)?
  • What is the most important information I should know about zoledronic acid (Reclast)?
  • What should I discuss with my healthcare provider before receiving zoledronic acid (Reclast)?
  • How is zoledronic acid given (Reclast)?
  • What happens if I miss a dose (Reclast)?
  • What happens if I overdose (Reclast)?
  • What should I avoid while receiving zoledronic acid (Reclast)?
  • What other drugs will affect zoledronic acid (Reclast)?
  • Where can I get more information?

What is zoledronic acid (Reclast)?

Zoledronic acid (sometimes called zoledronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronic acid inhibits the release of calcium from bones.

Zoledronic acid is used to treat Paget's disease, and high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zoledronic acid also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.

Zoledronic acid is also used to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis. Zoledronic acid is used to treat or prevent osteoporosis in people who will be taking certain steroid medicines for 12 months or longer.

Zoledronic acid may also be used for other purposes not listed in this medication guide.

What are the possible side effects of zoledronic acid (Reclast)?

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 any of these serious side effects:

  • urinating less than usual or not at all;
  • muscle spasms, numb or tingly feeling (especially around your mouth);
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising, unusual weakness;
  • severe joint, bone, or muscle pain; or
  • bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious side effects may include:

  • cough;
  • loss of appetite, nausea, vomiting;
  • diarrhea, constipation;
  • headache, tired feeling;
  • mild joint or muscle pain; or
  • redness or swelling where the needle was placed.

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.

What is the most important information I should know about zoledronic acid (Reclast)?

Do not receive zoledronic acid without telling your doctor if you have had an allergic reaction to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to zoledronic acid 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 pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with zoledronic acid. It may take longer than normal for you to recover.

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