This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use BORTEZOMIB GLENMARK 2.5 mg/mL INJECTABLE SOLUTION

Introduction

Package Leaflet:information for the patient

Bortezomib Glenmark 2.5 mg/ml solution for injection

Read all of this leaflet carefully before you start using this medicine,because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.

If you experience side effects, contact your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

What is Bortezomib Glenmark and what is it used for
What you need to know before you use Bortezomib Glenmark
How to use Bortezomib Glenmark
Possible side effects

5 Storage of Bortezomib Glenmark

Contents of the pack and further information

1. What is Bortezomib Glenmark and what is it used for

Bortezomib Glenmark contains the active substance bortezomib, a “proteasome inhibitor”. Proteasomes play an important role in controlling cell function and growth. Bortezomib can destroy cancer cells by interfering with their function.

Bortezomib is used to treat multiple myeloma (a type of bone marrow cancer) in patients over 18 years of age:

alone or with the medicines doxorubicin liposomal pegylated or dexamethasone, for patients whose disease is getting worse (in progression) after receiving at least one previous treatment and for those patients whose stem cell transplant did not work or is not suitable.
in combination with the medicines melphalan and prednisone, for patients who have not been treated before and are not suitable for high-dose chemotherapy before a stem cell transplant.
in combination with the medicines dexamethasone or dexamethasone and thalidomide, in patients who have not been treated before and are receiving high-dose chemotherapy before a stem cell transplant (induction treatment).

Bortezomib is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients who have not been treated before and for those patients who are not considered suitable for a stem cell transplant.

2. What you need to know before you use Bortezomib Glenmark

Do not use Bortezomib Glenmark

if you are allergic to bortezomib, boron, or any of the other ingredients of this medicine (listed in section 6).
if you have certain severe lung or heart problems.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start using Bortezomib Glenmark if you have:

low red or white blood cell count
bleeding problems and/or low platelet count in the blood
diarrhea, constipation, nausea, or vomiting
history of fainting, dizziness, or lightheadedness
kidney problems
moderate to severe liver problems
numbness, tingling, or pain in the hands or feet (neuropathy) in the past
heart problems or high blood pressure
difficulty breathing or coughing
seizures
shingles (localized, including around the eyes, or widespread)
symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss, or difficulty breathing
memory loss, thought disturbances, difficulty walking, or vision loss. These may be signs of a serious brain infection, and your doctor may advise further tests and monitoring.

You will need to have regular blood tests before and during treatment with bortezomib to check your blood cell count regularly.

You must tell your doctor if you have mantle cell lymphoma and are given rituximab with bortezomib:

if you think you have or have had hepatitis infection in the past. In a few cases, patients who have had hepatitis B can have repeated attacks of hepatitis, which can be fatal. If you have a history of hepatitis B infection, you will be closely monitored by your doctor for signs of active hepatitis B.

Before starting treatment with bortezomib, you should read the package leaflets of all the medicines you need to take with bortezomib to find out about the information related to these medicines. When using thalidomide, special attention should be paid to pregnancy testing and preventive measures (see Pregnancy and Breastfeeding in this section).

Children and adolescents

Bortezomib should not be used in children and adolescents because it is not known how it will affect them.

Other medicines and Bortezomib Glenmark

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are using medicines that contain any of the following active substances:

ketoconazole, to treat fungal infections
ritonavir, to treat HIV infection
rifampicin, an antibiotic to treat bacterial infections
carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy
St. John's Wort (Hypericum perforatum), used for depression or other conditions
oral antidiabetics

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use bortezomib if you are pregnant unless it is clearly necessary.

Both men and women using bortezomib must use effective contraception during and up to 3 months after treatment. If, despite these measures, you become pregnant, inform your doctor immediately.

You should not breastfeed while using bortezomib. Ask your doctor when it is safe to restart breastfeeding after finishing your treatment.

Thalidomide causes birth defects and fetal death. When bortezomib is given with thalidomide, you should follow the thalidomide pregnancy prevention program (see the thalidomide package leaflet).

Driving and using machines

Bortezomib may cause fatigue, dizziness, fainting, or blurred vision. Do not drive or use tools or machines if you experience these side effects; even if you do not experience them, you should be cautious.

Bortezomib Glenmarkcontains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially “sodium-free”.

3. How to use Bortezomib Glenmark

Your doctor will tell you the dose of bortezomib according to your height and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg/m2 of body surface area twice a week. Your doctor may change the dose and the total number of treatment cycles depending on your response to treatment, the occurrence of certain side effects, and your underlying condition (e.g., liver problems).

Progressive multiple myeloma

When bortezomib is given alone, you will receive 4 doses of bortezomib by intravenous or subcutaneous injection on days 1, 4, 8, and 11, followed by a 10-day “rest” period without treatment. This 21-day period (3 weeks) is one treatment cycle. You may receive up to 8 cycles (24 weeks).

You may also receive bortezomib with the medicines doxorubicin liposomal pegylated or dexamethasone.

When bortezomib is given with doxorubicin liposomal pegylated, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and doxorubicin liposomal pegylated 30 mg/m2 will be given by intravenous infusion on day 4 of the bortezomib 21-day treatment cycle, after the bortezomib injection. You may receive up to 8 cycles (24 weeks).

When bortezomib is given with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and dexamethasone 20 mg will be given orally on days 1, 2, 4, 5, 8, 9, 11, and 12 of the bortezomib 21-day treatment cycle. You may receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma

If you have not been treated for multiple myeloma before and are nota candidate for a stem cell transplant, you will receive bortezomib with the medicines melphalan and prednisone.

In this case, the duration of one treatment cycle is 42 days (6 weeks). You will receive 9 cycles (54 weeks).

In cycles 1 to 4, bortezomib is given twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
In cycles 5 to 9, bortezomib is given once a week on days 1, 8, 22, and 29.

Melphalan (9 mg/m2) and prednisone (60 mg/m2) are given orally during days 1, 2, 3, and 4 of the first week of each cycle.

If you have not received any previous treatment for multiple myeloma and area candidate for a stem cell transplant, you will receive bortezomib by intravenous or subcutaneous injection with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When bortezomib is given with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and dexamethasone will be given orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the bortezomib 21-day treatment cycle. You will receive 4 cycles (12 weeks).

When bortezomib is given with thalidomide and dexamethasone, the duration of one treatment cycle is 28 days (4 weeks).

Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the bortezomib 28-day treatment cycle, and thalidomide is given orally once daily at a dose of 50 mg up to day 14 of the first cycle, and if tolerated, the thalidomide dose may be increased to 100 mg from days 15-28, and from the second cycle onwards, it may be increased further to 200 mg daily. You may receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

If you have not been treated for mantle cell lymphoma before, you will receive bortezomib by intravenous or subcutaneous injection with the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib is given by intravenous or subcutaneous injection on days 1, 4, 8, and 11, followed by a “rest” period without treatment. The duration of one treatment cycle is 21 days (3 weeks). You may receive up to 8 cycles (24 weeks).

The following medicines are given by intravenous infusion on day 1 of the bortezomib 21-day treatment cycle:

Rituximab at a dose of 375 mg/m2, cyclophosphamide at a dose of 750 mg/m2, and doxorubicin at a dose of 50 mg/m2.

Prednisone is given orally at a dose of 100 mg/m2 on days 1, 2, 3, 4, and 5 of the bortezomib treatment cycle.

How Bortezomib Glenmark is given

This medicine is given by subcutaneous or intravenous injection. You will be given bortezomib by a healthcare professional who is experienced in the use of cytotoxic medicines.

The solution is injected into a vein or under the skin. The injection into a vein is rapid, lasting between 3 and 5 seconds. The injection under the skin is given into the thighs or abdomen.

If you are given moreBortezomib Glenmarkthan you should

This medicine will be given to you by your doctor or nurse, so it is unlikely that you will be given too much. In the unlikely event of an overdose, your doctor will monitor you for side effects.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Some of these effects can be serious.

If you are administered bortezomib for multiple myeloma or mantle cell lymphoma, report immediately to your doctor if you observe any of the following symptoms:

Muscle cramps, muscle weakness
Confusion, loss or alteration of vision, blindness, convulsions, headaches
Difficulty breathing, swelling of the feet or alterations in heart rhythm, high blood pressure, fatigue, fainting
Cough and difficulty breathing or oppression in the chest.

Treatment with bortezomib can very frequently cause a decrease in the number of red and white blood cells and platelets in the blood. Therefore, you will need to have regular blood tests before and during treatment with this medicine to regularly check your blood cell count. You may experience a reduction in the number of:

Platelets, which can make you more prone to bruising (bruises) or bleeding without apparent injury (e.g., intestinal, stomach, mouth, and gum bleeding or bleeding in the brain or liver bleeding)
Red blood cells, which can cause anemia, with symptoms such as fatigue and paleness
White blood cells, which can make you more prone to infections or symptoms similar to those of the flu.

If you are administered bortezomib for the treatment of multiple myeloma, the adverse effects you may experience are included below:

Very Common Adverse Effects (may affect more than 1 in 10 patients)

Sensitivity, numbness, tingling, or burning sensation in the skin or pain in hands or feet due to nerve damage
Decrease in the number of red and/or white blood cells (see above)
Fever
Feeling of discomfort (nausea) or vomiting, loss of appetite
Constipation with or without swelling (can be severe)
Diarrhea: if it appears, it is important to drink more water than usual. Your doctor may give you another medicine to control diarrhea
Exhaustion (fatigue), feeling of weakness
Muscle pain, bone pain

Common Adverse Effects (may affect up to 1 in 10 patients)

Low blood pressure, sudden drop in blood pressure when standing, which could lead to fainting
High blood pressure
Decreased kidney function
Headache
Feeling of general discomfort, pain, dizziness, drowsiness, feeling of weakness or loss of consciousness
Chills
Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, cough with phlegm, flu-like illness
Herpes zoster (localized including around the eyes or spread throughout the body)
Chest pain or difficulty breathing when exercising
Various types of rashes
Itching of the skin, skin bumps, or dry skin
Facial flushing or rupture of small blood vessels
Redness of the skin
Dehydration
Heartburn, bloating, belching, flatulence, stomach pain, intestinal or stomach bleeding
Alteration of liver function
Sores in the mouth or lip, dry mouth, mouth ulcers, or sore throat
Weight loss, loss of taste
Muscle cramps, muscle spasms, muscle weakness, pain in the limbs
Blurred vision
Infection of the outer layer of the eye and the inner surface of the eyelids (conjunctivitis)
Nosebleeds
Difficulty or problems sleeping, sweating, anxiety, mood changes, depressed mood, restlessness or agitation, changes in mental state, disorientation
Swelling of the body, including around the eyes and in other parts of the body

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

Heart problems, including heart attack, angina pectoris
Severe nerve inflammation, which can cause paralysis and breathing difficulties (Guillain-Barré syndrome)
Flushing
Discoloration of the veins
Inflammation of the spinal nerves
Ear problems, ear bleeding
Underactive thyroid gland
Budd-Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins)
Changes or anomalies in intestinal function
Cerebral hemorrhage
Yellowing of the eyes and skin (jaundice)
Severe allergic reaction (anaphylactic shock), whose signs can be difficulty breathing, pain or oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse
Breast disorders
Vaginal tear
Inflammation of the genitals
Inability to tolerate alcohol consumption
Emaciation or loss of body mass
Increased appetite
Fistula
Joint effusion
Cysts in the joint lining (synovial cysts)
Fracture
Breakdown of muscle fibers that causes other complications
Liver swelling, liver bleeding
Kidney cancer
Skin disease similar to psoriasis
Skin cancer
Pallor of the skin
Increased platelets or plasma cells (a type of white blood cell) in the blood
Blood clot in small blood vessels (thrombotic microangiopathy)
Abnormal reaction to blood transfusions
Partial or total loss of vision
Loss of libido
Drooling
Bulging eyes
Sensitivity to light
Rapid breathing
Rectal pain
Gallstones
Hernia
Wounds
Weak or brittle nails
Abnormal protein deposits in vital organs
Coma
Intestinal ulcers
Multi-organ failure
Death

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

Heart problems, including heart attack, angina pectoris
Severe nerve inflammation, which can cause paralysis and breathing difficulties (Guillain-Barré syndrome)
Flushing
Discoloration of the veins
Inflammation of the spinal nerves
Ear problems, ear bleeding
Underactive thyroid gland
Budd-Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins)
Changes or anomalies in intestinal function
Cerebral hemorrhage
Yellowing of the eyes and skin (jaundice)
Severe allergic reaction (anaphylactic shock), whose signs can be difficulty breathing, pain or oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse
Breast disorders
Vaginal tear
Inflammation of the genitals
Inability to tolerate alcohol consumption
Emaciation or loss of body mass
Increased appetite
Fistula
Joint effusion
Cysts in the joint lining (synovial cysts)
Fracture
Breakdown of muscle fibers that causes other complications
Liver swelling, liver bleeding
Kidney cancer
Skin disease similar to psoriasis
Skin cancer
Pallor of the skin
Increased platelets or plasma cells (a type of white blood cell) in the blood
Blood clot in small blood vessels (thrombotic microangiopathy)
Abnormal reaction to blood transfusions
Partial or total loss of vision
Loss of libido
Drooling
Bulging eyes
Sensitivity to light
Rapid breathing
Rectal pain
Gallstones
Hernia
Wounds
Weak or brittle nails
Abnormal protein deposits in vital organs
Coma
Intestinal ulcers
Multi-organ failure
Death

If you are administered bortezomib along with other medicines for the treatment of mantle cell lymphoma, the adverse effects you may experience are included below:

Very Common Adverse Effects (may affect more than 1 in 10 patients)

Pneumonia
Loss of appetite
Sensitivity, numbness, tingling, or burning sensation in the skin or pain in hands or feet due to nerve damage
Nausea or vomiting
Diarrhea
Sores in the mouth
Constipation
Muscle pain, bone pain
Hair loss and abnormal hair texture
Exhaustion, feeling of weakness
Fever

Common Adverse Effects (may affect up to 1 in 10 patients)

Herpes zoster (localized including around the eyes or spread throughout the body)
Herpes virus infection
Bacterial and viral infections
Respiratory infections, bronchitis, cough with phlegm, flu-like illness
Fungal infections
Hypersensitivity (allergic reaction)
Inability to produce sufficient insulin or resistance to normal insulin levels
Fluid retention
Difficulty or problems sleeping
Loss of consciousness
Alteration of consciousness, confusion
Dizziness
Increased heart rate, high blood pressure, sweating
Abnormal vision, blurred vision
Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate
High or low blood pressure
Sudden drop in blood pressure when standing, which could lead to fainting
Difficulty breathing when exercising
Cough
Hiccup
Ringing in the ears, ear discomfort
Intestinal or stomach bleeding
Heartburn
Stomach pain, bloating
Difficulty swallowing
Infection or inflammation of the stomach and intestines
Stomach pain
Sores in the mouth or lip, sore throat
Alteration of liver function
Itching of the skin
Redness of the skin
Rash
Muscle spasms
Urinary tract infections
Pain in the limbs
Swelling of the body, including around the eyes and in other parts of the body
Chills
Redness and pain at the injection site
Feeling of general discomfort
Weight loss
Weight gain

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

Hepatitis
Severe allergic reaction (anaphylactic reaction), whose signs can be difficulty breathing, pain or oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse
Movement disorders, paralysis, tremors
Dizziness
Hearing loss, deafness
Disorders that affect the lungs, preventing the body from receiving enough oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that can become shallow, difficult, or stop, rapid breathing
Blood clots in the lungs
Yellowing of the eyes and skin (jaundice)

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

Blood clot in small blood vessels (thrombotic microangiopathy)
Severe nerve inflammation, which can cause paralysis and breathing difficulties (Guillain-Barré syndrome)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Bortezomib Glenmark

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label and box after "EXP". The expiration date is the last day of the month indicated.

Store in the refrigerator (2 °C - 8 °C).

Keep the vial in the outer packaging to protect it from light.

After opening/reconstitution/dilution:

Chemical and physical stability in use has been demonstrated after the first opening and/or dilution for 28 days when stored at 2 °C - 8 °C and protected from light, 7 days when stored at 25 °C and protected from light or 24 hours when stored at 25 °C and under normal indoor lighting conditions in the original vial and/or in a polypropylene syringe.

From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and will normally not exceed 24 hours between 2 and 8°C.

Regarding stability in the syringe, the same storage time applies to the diluted solution and the undiluted solution.

Bortezomib is for single use. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Container Contents and Additional Information

Composition of Bortezomib Glenmark

The active ingredient is bortezomib. Each vial with 1 ml or 1.4 ml of injectable solution contains 2.5 mg/ml of bortezomib (as boronic acid ester of mannitol).

The other components (excipients) are mannitol (E421), sodium chloride, hydrochloric acid, and water for injectable preparations.

Intravenous route:

After dilution, 1 ml of solution for intravenous injection contains 1 mg of bortezomib.

Subcutaneous route:

1 ml of solution for subcutaneous injection contains 2.5 mg of bortezomib.

Appearance of the Product and Container Contents

Bortezomib Glenmark is a clear, colorless to slightly yellowish solution.

Transparent glass vial with a rubber stopper and a red aluminum flip-off cap, containing 1 ml of solution.

Transparent glass vial with a rubber stopper and a blue aluminum flip-off cap, containing 1.4 ml of solution.

Container Sizes

1 vial of 1 ml

1 vial of 1.4 ml

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

APIS Labor GmbH

Resslstraße 9

9065 Ebenthal in Kärnten

Austria

Synoptis Industrial Sp. Z.o.o.

ul. Rabowicka 15, Swarzedz

wielkopolskie, 62-020

Poland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country	Medicinal Product Name
Germany	Bortezomib Glenmark 2.5 mg/ml Injektionslösung
Netherlands	Bortezomib Glenmark 2.5 mg/ml oplossing voor injectie
Finland	Bortezomib Glenmark
Sweden	Bortezomib Glenmark
Norway	Bortezomib Glenmark
Denmark	Bortezomib Glenmark
Spain	Bortezomib Glenmark 2.5 mg/ml solución inyectable
France	Bortézomib Glenmark 2.5 mg/ml pour solution injectable
Italy	Bortezomib Glenmark 2.5 mg/ml per soluzione iniettabile

Date of the last revision of this leaflet:October 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended for healthcare professionals only:

Note: Bortezomib is a cytotoxic agent. Therefore, caution should be exercised during handling and preparation. The use of gloves and other protective clothing is recommended to prevent skin contact.

Pregnant women should not handle this medicinal product.

SINCE BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES, IT IS RECOMMENDED TO STRICTLY FOLLOW ASEPTIC TECHNIQUE DURING ITS HANDLING.

PREPARATION FOR INTRAVENOUS INJECTION

Preparation of a 2.5 mg/1 ml vial: add 1.5 mlof 9 mg/ml (0.9%) sodium chloride injectable solution to the vial containing bortezomib.

Preparation of a 3.5 mg/1.4 ml vial: add 2.1 mlof 9 mg/ml (0.9%) sodium chloride injectable solution to the vial containing bortezomib.

The concentration of the resulting solution will be 1 mg/ml. The solution should be clear, colorless to pale yellow, with a final pH of 4 to 7. It is not necessary to check the pH of the solution.

Before administration, visually inspect the solution to rule out the presence of particles and discoloration. If any discoloration or particles are observed, the solution should be discarded. Check that the correct dose is being used for intravenous administration (1 mg/ml).

The chemical and physical stability has been demonstrated for 28 days when stored at 2 °C – 8 °C and protected from light, 7 days when stored at 25 °C and protected from light, or 24 hours when stored at 25 °C and under normal indoor lighting conditions in the original vial and/or in a polypropylene syringe.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally will not exceed 24 hours between 2 and 8 °C.

During preparation for administration and during administration itself, it is not necessary to protect the medicinal product from light.

ADMINISTRATION

Once diluted, withdraw the appropriate amount of the diluted solution based on the calculated dose according to the patient's Body Surface Area.
Confirm the dose and concentration contained in the syringe before use (check that the syringe is marked for intravenous administration).
Inject the solution through a peripheral or central intravenous catheter in a vein, using a 3-5 second bolus injection.
Flush the peripheral or intravenous catheter with sterile 9 mg/ml (0.9%) sodium chloride solution.

Bortezomib Glenmark 2.5 mg/ml injectable solution SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY OR SUBCUTANEOUSLY. Do not administer by other routes. Intrathecal administration has caused death.

ELIMINATION

A vial is for single use and the remaining solution should be discarded.

The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations for cytotoxic agents.