Novelzo (Bortezomib 1mg)

NORVELZO 3.5 mg
Powder for solution for injection

Each vial contains 3.5 mg bortezomib
(as a mannitol boronic ester).
After reconstitution,
1 ml of solution for subcutaneous injection
Contains 3.5 mg bortezomib.
After reconstitution, 1 ml of solution for
Intravenous injection contains 3.5 mg bortezomib.

- White to off-white cake or powder. NORVELZO 3.5 mg as monotherapy is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for 3.5 MG BORTEZOMIB (as a mannitol boronic ester)

NORVELZO 3.5 mg in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

What is in this leaflet :

This leaflet answers some common questions about NORVELZO® Powder for Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given NORVELZO® against the benefits this medicine is expected to have for you.If you have any concerns about being given NORVELZO® ask your doctor. Keep this leaflet while being treated. You may need to read it again.

How NORVELZO® (bortezomib) works

NORVELZO® (bortezomib) is a type of chemotherapy called a targeted therapy that is approved by the FDA for the treatment of multiple myeloma and relapsed mantle cell lymphoma in a class of medicines called proteasome inhibitors. NORVELZO® has been studied in 5 important clinical trials. Since its approval, NORVELZO® has been used to treat an estimated 350,000 patients* worldwide. It has been studied in a wide range of patient types, including those with renal impairment and diabetes.

As a targeted therapy, NORVELZO® works by blocking or slowing down the action of proteasomes inside cells. The function of proteasomes is to break down proteins in both healthy and cancerous cells.

When proteasome activity is blocked or slowed down, proteins in the cells accumulate. This accumulation may cause cells—especially cancerous cells—to stop growing, dividing, and multiplying, causing them to die. Because cancer cells divide and multiply more rapidly than most other cells, the goal of treatment with NORVELZO® is to target these rapidly dividing cells and stop them from thriving and multiplying.

How NORVELZO® (bortezomib) is given:

NORVELZO® (bortezomib) may be administered in 1 of 2 ways: a subcutaneous or intravenous (IV) injection. Both ways are administered in a doctor’s office or at a clinic.

Subcutaneous NORVELZO is injected under the skin, which may be referred to as an SC injection Intravenous NORVELZO is injected into a vein, which may be referred to as an I.V injection NORVELZO is contraindicated for intrathecal administration

Receiving NORVELZO® (bortezomib)

NORVELZO® (bortezomib) may be given as part of a combination therapy or alone. Like many cancer medications, NORVELZO is given in cycles. A cycle of therapy usually includes the number of weeks when you will receive the drug and the week(s) you will rest and not receive the drug. The length and number of cycles (weeks) depend on several factors, including how well a patient responds to treatment and whether side effects occur.

You and your healthcare team will decide the best way for you to receive NORVELZO and for how long.

Benets and risks of treatment with NORVELZO® (bortezomib) Just as there may be benefits to your treatment with NORVELZO® (bortezomib), there may be risks as well. It's important to understand all of the possible side effects. If you experience side effects, be sure to talk to your healthcare team, as there are ways for side effects to be effectively managed.

What is NORVELZO used for?

NORVELZO (bortezomib) is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). NORVELZO is also approved for the treatment of patients with mantle cell lymphoma (a cancer of the lymph nodes) who have already received other treatments.

How is NORVELZO administered?

NORVELZO is prescribed by a physician experienced in the use of medications to treat cancer. It is administered by a healthcare professional as an injection into your vein (intravenously, or IV) or under your skin (subcutaneously). NORVELZO must not be administered into your spinal fluid (intrathecally).

Who should not receive NORVELZO?

Before you receive treatment with NORVELZO, tell your doctor about all of your medical conditions. You should not receive NORVELZO if you are allergic to bortezomib, boron, or mannitol.

What are the possible side effects of NORVELZO?

NORVELZO (bortezomib) can cause serious side effects, including: Peripheral neuropathy. NORVELZO can cause damage to the nerves, a condition called peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. Tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of NORVELZO or stop it altogether. If you have peripheral neuropathy before starting NORVELZO, your doctor could consider giving you NORVELZO subcutaneously.

Low blood pressure. NORVELZO can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy, or feel as though you might faint. If you are taking drugs that lower blood pressure, your medications might need to be adjusted. If you are not drinking enough liquids, your doctor may need to administer IV fluids.

Heart problems. Treatment with NORVELZO can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. Tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.

Lung problems. There have been reports of lung disorders in patients receiving NORVELZO. Some of these events have been fatal. Tell your doctor if you experience any cough, shortness of breath, wheezing, or difficulty breathing.

Liver problems. If you have liver problems, it can be harder for your body to get rid of NORVELZO. NORVELZO has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease.

Posterior reversible encephalopathy syndrome (PRES). There have been reports of a rare, reversible condition involving the brain, called PRES, in patients treated with NORVELZO. Patients with PRES can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems. Treatment with NORVELZO should be stopped in cases of PRES. Gastrointestinal problems. NORVELZO (bortezomib) treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.

Neutropenia (low levels of neutrophils, a type of white blood cell). NORVELZO can cause low levels of white blood cells (infection-fighting cells). If your white blood cells become low, you can be at higher risk for infections. Tell your doctor if you develop a fever or believe you have an infection. Thrombocytopenia (low levels of platelets). NORVELZO can cause low levels of platelets (clotforming cells). If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion.

You will have regular blood tests to check your cell counts during your treatment with NORVELZO. If the number of these cells is very low, your doctor may change the dose and/or schedule of NORVELZO.

Tumor lysis syndrome (TLS). TLS is a syndrome that causes a chemical imbalance in the blood that could lead to heart and/or kidney problems. TLS can occur with cancer treatments, and your doctor will be monitoring your blood and urine for any signs of this syndrome. If you develop TLS, your doctor will take appropriate steps to treat it.

More than 1 in 5 patients (20%) receiving NORVELZO have experienced the following side effects: nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia (nerve pain), anemia, leukopenia (low levels of white blood cells), constipation, vomiting, lymphopenia (low levels of a certain type of white blood cells), rash, pyrexia (fever), and anorexia.

What other information should you discuss with your doctor?

Women should avoid becoming pregnant or breast-feeding while being treated with NORVELZO (bortezomib).
Discuss with your doctor when it is safe to restart breast-feeding after nishing your treatment.

A prospective, international, randomized (1:1), open-label clinical study of 682 patients was conducted to determine whether NORVELZO® administered intravenously (1.3 mg/m2) in combination with melphalan(9 mg/m2) and prednisone (60 mg/m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.

Antiviral prophylaxis was recommended for patients on the NORVELZO® study arm. In the NORVELZO® arm, 34% of patients received at least one NORVELZO® dose in all 8 of the 3-week cycles of therapy, and 13% received at least one dose in all 11 cycles. The average number of NORVELZO® doses during the study was 22, with a range of 1 to 44. In the dexamethasone arm, 40% of patients received at least one dose in all 4 of the 5-week treatment cycles of therapy, and 6% received at least one dose in all 9 cycles.

PATIENT COUNSELING INFORMATION

Physicians are advised to discu ss the following with patients prior to treatment with NORVELZO®: Ability to Drive or Operate Machinery or Impairment of Mental Ability NORVELZO may cause fatigue, dizziness, syncope, orthostatic / postural hypotension. Advise patients not to drive or operate machinery if they experience any of these symptoms.

Dehydration/Hypotension Patients receiving NORVELZO® therapy may experience vomiting and/or diarrhea. Advise patients how to avoid dehydration. Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells.

Pregnancy/Nursing : Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with NORVELZO®. Instruct patients to report pregnancy to their physicians immediately. Advise patients that they should not receive NORVELZO® while pregnant or breast-feeding. If a patient wishes to restart breastfeeding after treatment, she should be advised to discuss the appropriate timing with her physician.

Concomitant Medications : Advise patients to speak with their physicians about any other medication they are currently taking.

Diabetic Patients : Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level.

Peripheral Neuropathy : Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs.

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