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Other Information for Your Practice

Beyond the information for you here at InterventionZ, there is a multitude of other information available for you to access that can help support you and your patients living with bone metastases and multiple myeloma. We hope you'll take some time to explore the following programs and links and that they will assist you as you continue providing the highest level of care to your patients.

Patient Assistance NOW Oncology (PANO)

Novartis Oncology shares your commitment to helping patients living with cancer receive the medicines they need. Patient Assistance NOW Oncology offers quick and easy access to information about the broad array of reimbursement and support programs available for your patients. You can get information about our support programs in two ways:

Use the Novartis Oncology Program Finder tool, designed to help determine if your patients are eligible for a program that can help them gain access to the Novartis Oncology medicines they need .
Call 1-800-282-7630 to speak to one of our knowledgeable staff dedicated to making access to our programs as simple and convenient as possible.

Support includes:

Insurance verification
Medicare education
Assistance with denials/appeals
Therapy-specific support programs for out-of-pocket costs
Assistance searching for other sources of coverage/funding that could alleviate or reduce costs for patients
Referrals to independent charitable foundations for assistance with co-pay costs
Patient assistance for low-income and uninsured patients
Patients pre-qualified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application

The ZOMETA
Medical Benefit Savings Card: Co-payment Assistance Made Easier

A FREE program that may help eligible patients manage the cost of ZOMETA treatment.

Covers 100% of the out-of-pocket cost of the first ZOMETA treatment
Each following treatment costs you only $25
May be used once every 3 to 4 weeks to accommodate your treatment schedule
Covers up to $2500 each year
Eligible patients can re-apply each year for continued assistance

Enrolling your patients is easy: Just call 1-888-966-3826 and be ready with answers to the following questions:

Does your patient's insurance cover ZOMETA?
Is your patient's total annual household income less than 350% of the federal poverty level?

*For patients to qualify for medical benefits under the ZOMETA Card, they CANNOT be on Medicare, Medicaid, or any other publicly funded program, or live in Massachusetts.

ZOMETA Product Information Line

A toll-free service that can help with reimbursement or insurance-related issues Call 1-866-4-ZOMETA (1-866-496-6382) Monday through Friday, 9 AM to 8 PM ET

Patient Support Resources

Compass: An Education & Support Resource for Your Patients

Compass is a website and a patient program created to provide your patients with in-depth information about their bone health, bone metastases, multiple myeloma and treatment with ZOMETA. By enrolling in Compass, your patients will receive a personalized Doctor Discussion Guide to help them prepare in advance for their appointments with you and other members of their healthcare team.

In addition, they'll receive a series of e-mails providing information and resources to help them learn more. Compass offers patients:

Answers to FAQs at an interactive Patient Information Center
Resources for support, including a customized Side Effects Guide and Support Resources Guide
Videos of patients talking about living with bone complications from breast cancer, hormone refractory prostate cancer, and multiple myeloma
A Caregiver Corner with supportive advice for family and friends

Encourage your patients to enroll in Compass or visit the site to learn more.

ZometaCares Patient Support Program

If your patients have additional questions about their treatment, ZometaCares can answer them. ZometaCares has experienced oncology nurses on call just to answer their treatment-related questions—and help them keep their scheduled appointments.

ZometaCares is a supportive program designed to supplement the care you're already providing. With ZometaCares your patients always have someone to turn to. When you're not available to answer questions—after hours or if you're with another patient—you can feel confident that another experienced Oncology healthcare provider can help answer questions, and address any lifestyle issues, about ZOMETA. Your patients can enroll by phone—simply have them call
1-888-3-ZOMETA (1-888-396-6382), Monday-Friday, 9:30 am - 10:00 pm EST/EDT.

The Virtual Oncology
Center (VOC)

The VOC is an online medical information tool for healthcare professionals involved in the treatment of cancer patients with multiple myeloma and bone metastases from solid tumors. Resources available in the VOC include patient cases, Q & A videos, nursing print materials, and links to professional nursing organizations.These resources have been developed by leading oncologists and nurses and are designed so you may help improve patient outcomes. To take advantage of all that the VOC has to offer, click here now.

Additional Links for Information

For additional information for your practice, click here.

ZOMETA is contraindicated in patients with hypersensitivity to zoledronic acid or any components of ZOMETA. Hypersensitivity reactions, including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock, have been reported. Patients being treated with ZOMETA should not be treated with Reclast^® (zoledronic acid) as they contain the same active ingredient.

Patients with HCM must be adequately rehydrated prior to use of ZOMETA and loop diuretics (if applicable). Loop diuretics should be used with caution in combination with ZOMETA to avoid hypocalcemia. ZOMETA should be used with caution with other nephrotoxic drugs. Carefully monitor serum calcium, phosphate, magnesium, and serum creatinine following initiation of ZOMETA. Short-term supplemental therapy may be necessary.

In patients with impaired renal function, the risk of adverse reactions (especially renal adverse reactions) may be greater. Consider individual patient risk/benefit profile before starting ZOMETA therapy in HCM patients with severe renal impairment. ZOMETA treatment is not recommended in patients with bone metastases with severe renal impairment. Preexisting renal insufficiency and multiple cycles of ZOMETA and other bisphosphonates are risk factors for subsequent renal deterioration with ZOMETA. Do not use doses greater than 4 mg. ZOMETA should be administered by IV infusion over no less than 15 minutes. Monitor serum creatinine before each dose.

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ. Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, local trauma, including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection, including osteomyelitis. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures, if possible, as recovery may be prolonged. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

ZOMETA should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant or plans to breast-feed while taking this drug, the patient should be apprised of the potential harm to the fetus or baby.

In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates including ZOMETA. Discontinue use if severe symptoms develop, and a subset of patients had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. There have been reports of bronchoconstriction in aspirin sensitive patients receiving bisphosphonates.

Insufficient data exist on how to safely use ZOMETA in HCM patients with hepatic impairment.

Acute-phase reaction symptoms can occur in HCM patients, with fever most commonly reported (44% with ZOMETA vs. 33% with pamidronate). Patients may occasionally experience flu-like syndrome (fever, chills, flushing, bone pain and/or arthralgias and myalgias). The most common adverse events (≥10%) in HCM clinical trials, regardless of causality, with ZOMETA 4 mg (n=86) were as follows: fever (44%), nausea (29%), constipation (27%), anemia (22%), dyspnea (22%), diarrhea (17%), abdominal pain (16%), progression of cancer (16%), insomnia (15%), vomiting (14%), anxiety (14%), urinary tract infection (14%), hypophosphatemia (13%), confusion (13%), agitation (13%), moniliasis (12%), hypokalemia (12%), coughing (12%), skeletal pain (12%), hypotension (11%), and hypomagnesemia (11%). In controlled HCM clinical trials, adverse events (5-10% frequency) occurring in greater incidence with ZOMETA than pamidronate include: asthenia, chest pain, leg edema, mucositis, dysphagia, granulocytopenia, thrombocytopenia, pancytopenia, non-specific infection, hypocalcemia, dehydration, arthralgias, headache and somnolence. Injection site reactions (redness, swelling) have been infrequently reported.

The most common adverse events (≥15%) in bone metastases clinical trials, regardless of causality, with ZOMETA 4 mg (n=1031) were as follows: bone pain (55%), nausea (46%), fatigue (39%), anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%), and paresthesia (15%). Patients should also be made aware of the potential for abdominal pain.

Ocular adverse events may occur with bisphosphonates, including ZOMETA. Cases of uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema have been reported during postmarketing use. In some cases, symptoms resolved with topical steroids.

Caution is advised when bisphosphonates, including ZOMETA, are administered with aminoglycosides, loop diuretics, and potentially nephrotoxic drugs.

Patients with multiple myeloma and bone metastases due to solid tumors should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Click here for ZOMETA Important Safety Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION

ZOMETA^® (zoledronic acid) 4mg/5mL Injection is indicated for the treatment of hypercalcemia of malignancy (HCM) and patients with multiple myeloma and documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Safe and efficacious use of ZOMETA has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.

IMPORTANT SAFETY INFORMATION

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ.
Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, local trauma, including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection, including osteomyelitis. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures, if possible, as recovery may be prolonged. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

Insufficient data exist on how to safely use ZOMETA in HCM patients with hepatic impairment.

Acute–phase reaction symptoms can occur in HCM patients, with fever most commonly reported (44% with ZOMETA vs. 33% with pamidronate). Patients may occasionally experience flu–like syndrome (fever, chills, flushing, bone pain and/or arthralgias and myalgias). The most common adverse events (≥10%) in HCM clinical trials, regardless of causality, with ZOMETA 4 mg (n=86) were as follows: fever (44%), nausea (29%), constipation (27%), anemia (22%), dyspnea (22%), diarrhea (17%), abdominal pain (16%), progression of cancer (16%), insomnia (15%), vomiting (14%), anxiety (14%), urinary tract infection (14%), hypophosphatemia (13%), confusion (13%), agitation (13%), moniliasis (12%), hypokalemia (12%), coughing (12%), skeletal pain (12%), hypotension (11%), and hypomagnesemia (11%). In controlled HCM clinical trials, adverse events (5–10% frequency) occurring in greater incidence with ZOMETA than pamidronate include: asthenia, chest pain, leg edema, mucositis, dysphagia, granulocytopenia, thrombocytopenia, pancytopenia, non-specific infection, hypocalcemia, dehydration, arthralgias, headache and somnolence. Injection site reactions (redness, swelling) have been infrequently reported.

Caution is advised when bisphosphonates, including ZOMETA, are administered with aminoglycosides, loop diuretics, and potentially nephrotoxic drugs.

Patients with multiple myeloma and bone metastases due to solid tumors should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing Information

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