Bortezomib Glenmark

Patient Information Leaflet

Bortezomib Glenmark 2.5 mg/ml solution for injection

Bortezomib
Generic medicine
Please read all of this leaflet carefully before you use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Bortezomib Glenmark is and what it is used for
2. What you need to know before using Bortezomib Glenmark
3. How to use Bortezomib Glenmark
4. Possible side effects
5. How to store Bortezomib Glenmark
6. Contents of the pack and other information

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

Bortezomib Glenmark contains the active substance bortezomib, a so-called "proteasome inhibitor". Proteasomes play an important role in controlling cell functions and cell growth. By interfering with their function, bortezomib can kill tumour cells.
Bortezomib Glenmark is used to treat multiple myeloma (a type of malignant neoplasm of the bone marrow) in patients aged over 18 years:

• alone or in combination with pegylated liposomal doxorubicin or dexamethasone, for patients with disease that has worsened (progressed) after receiving at least one prior treatment, or in whom blood stem cell transplantation has not been successful or is not feasible
• in combination with melphalan and prednisone, for patients with previously untreated disease who cannot receive high-dose chemotherapy with blood stem cell transplantation
• in combination with dexamethasone or dexamethasone together with thalidomide, for patients with previously untreated disease and prior to receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment)

Bortezomib Glenmark is used to treat mantle cell lymphoma (a type of malignant neoplasm affecting the lymph nodes) in patients aged 18 years or older, in combination with the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone, for previously untreated patients for whom blood stem cell transplantation is not feasible.

2. What you need to know before using 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 severe lung or heart problems.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bortezomib Glenmark if you:

• have low red blood cell or white blood cell counts
• have bleeding problems and/or low platelet counts in the blood
• have diarrhoea, constipation, nausea, or vomiting
• have previously experienced fainting, dizziness, or a feeling of lightheadedness
• have kidney problems
• have moderate to severe liver problems
• have previously had numbness, tingling, or pain in the hands or feet (neuropathy)
• have a heart condition or blood pressure problems
• have shortness of breath or cough
• have seizures
• have shingles (including localized around the eyes or spreading to other parts of the body)
• have symptoms of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or shortness of breath
• experience memory loss, difficulty thinking, difficulty walking, or loss of vision. These may be signs of a serious brain infection, and your doctor may recommend further tests and monitoring.

You will need to have regular blood tests before and during treatment with bortezomib to monitor your blood cell counts.
If you have mantle cell lymphoma and are being treated with rituximab in combination with this medicine, inform your doctor:

• if you think you have hepatitis or have had it in the past. In some cases, patients who have had hepatitis B may experience a reactivation of the disease, which can be fatal. If you have previously had a hepatitis B infection, your doctor will need to closely monitor you for signs and symptoms of active hepatitis B.

Read the package leaflets of all medicines you are taking in combination with bortezomib for information about these medicines before starting treatment with bortezomib. When this medicine is administered together with thalidomide, pay special attention to the instructions regarding pregnancy testing and the pregnancy prevention programme (see “Pregnancy and breastfeeding” in this section).

Children and adolescents
This medicine must not be used in children and adolescents because it is not known how the medicine works in these populations.

Other medicines and Bortezomib Glenmark
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• ketoconazole, used to treat fungal infections
• ritonavir, used to treat HIV infection
• rifampicin, an antibiotic used to treat bacterial infections
• carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy
• St John’s wort (Hypericum perforatum), used to treat depression or other conditions
• oral antidiabetic medicines.

Pregnancy and breastfeeding
You must not use this medicine during pregnancy unless strictly necessary.
Men and women undergoing treatment with Bortezomib Glenmark must use effective contraception during treatment and for at least 3 months after treatment ends. If pregnancy occurs despite these precautions, inform your doctor immediately.
You must not breastfeed while taking this medicine. Discuss with your doctor the most appropriate time to resume breastfeeding after treatment ends.
The medicine thalidomide causes birth defects and fetal death. When Bortezomib Glenmark is administered together with thalidomide, you must follow the thalidomide pregnancy prevention programme (see the thalidomide package leaflet).

Driving and using machines
This medicine may cause fatigue, dizziness, fainting, or blurred vision. Do not drive or operate machinery if you experience any of these symptoms. Exercise particular caution even if these effects are not apparent.

Bortezomib Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially ‘sodium-free’.

3. How to use Bortezomib Glenmark

Your doctor will calculate the dose of Bortezomib Glenmark based on your height and weight (body surface area). The standard starting dose of bortezomib is 1.3 mg/m² of body surface area twice weekly.
Your doctor may adjust the dose and the total number of treatment cycles depending on your response to treatment, the occurrence of certain side effects, and your overall health status (e.g. liver problems).

Relapsed multiple myeloma
When Bortezomib Glenmark is administered alone, you will receive 4 doses of bortezomib intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a 10-day "rest period" without treatment. This 21-day period (3 weeks) corresponds to one treatment cycle. You may receive up to 8 cycles (24 weeks).
You may also receive Bortezomib Glenmark in combination with pegylated liposomal doxorubicin or dexamethasone.
When Bortezomib Glenmark is administered together with pegylated liposomal doxorubicin, you will receive a 21-day treatment cycle with bortezomib administered intravenously or subcutaneously, and 30 mg/m² of pegylated liposomal doxorubicin will be administered on day 4 of the 21-day Bortezomib Glenmark treatment cycle as an intravenous infusion after the injection of Bortezomib Glenmark. You may receive up to 8 cycles (24 weeks of treatment).
When Bortezomib Glenmark is administered together with dexamethasone, you will receive a 21-day treatment cycle with bortezomib administered intravenously or subcutaneously, and oral dexamethasone at a dose of 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the 21-day Bortezomib Glenmark treatment cycle. You may receive up to 8 cycles (24 weeks of treatment).

Previously untreated multiple myeloma
If you have never been treated before for multiple myeloma and you are not eligible for blood stem cell transplantation, you will receive Bortezomib Glenmark in combination with two other 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 Glenmark is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, Bortezomib Glenmark is administered once weekly on days 1, 8, 22, and 29.

Melphalan (9 mg/m²) and prednisone (60 mg/m²) are administered orally on days 1, 2, 3, and 4 of the first week of each cycle.
If you have never been treated before for multiple myeloma and you are eligible for blood stem cell transplantation, you will receive Bortezomib Glenmark intravenously or subcutaneously in combination with dexamethasone, or with dexamethasone and thalidomide, as induction treatment.
When Bortezomib Glenmark is administered together with dexamethasone, you will receive a 21-day treatment cycle with bortezomib administered intravenously or subcutaneously and oral dexamethasone 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 21-day Bortezomib Glenmark treatment cycle. You will receive 4 cycles (12 weeks of treatment).
When Bortezomib Glenmark is administered together with thalidomide and dexamethasone, the treatment cycle duration is 28 days (4 weeks).
Dexamethasone 40 mg is administered orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day treatment cycle with Bortezomib Glenmark, and thalidomide is administered daily orally at a dose of 50 mg up to day 14 of the first cycle; if tolerated, the thalidomide dose is increased to 100 mg on days 15–28 and may subsequently be increased up to 200 mg daily starting from the second cycle onwards. You may receive up to 6 cycles (24 weeks of treatment).

Previously untreated mantle cell lymphoma
If you have never previously received specific treatment for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.
Bortezomib Glenmark is administered intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a "rest period" without treatment. The treatment cycle duration is 21 days (3 weeks). You may receive up to 8 treatment cycles (24 weeks).
The following medicines are administered on day 1 of each 21-day Bortezomib Glenmark treatment cycle as intravenous infusions:

• rituximab at 375 mg/m², cyclophosphamide at 750 mg/m², and doxorubicin at 50 mg/m²
• prednisone is administered orally at a dose of 100 mg/m² on days 1, 2, 3, 4, and 5 of the Bortezomib Glenmark treatment cycle.

How Bortezomib Glenmark is administered
This medicine is for intravenous and subcutaneous use. Bortezomib Glenmark will be administered by a healthcare professional experienced in the use of cytotoxic medicines.
The solution is injected subcutaneously. The diluted solution is injected into a vein. The intravenous injection is rapid, taking between 3 and 5 seconds. The subcutaneous injection can be given either in the thigh or in the abdomen.

If you receive more Bortezomib Glenmark than you should
Since this medicine is administered by a doctor or nurse, it is unlikely that you will receive more than you should. In the unlikely event of an overdose, your doctor will monitor you for any side effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects may be serious.
If you are being treated with this medicine for multiple myeloma or mantle cell lymphoma, inform your doctor immediately if you notice any of the following symptoms:

• Muscle cramps, muscle weakness
• Confusion, vision disturbances or loss of vision, blindness, seizures, headache
• Shortness of breath, swelling of the feet or changes in heartbeat, high blood pressure, fatigue, fainting
• Cough and difficulty breathing or chest tightness.

Treatment with bortezomib can very commonly cause a decrease in the number of red and white blood cells and platelets in the blood. Therefore, you will need regular blood tests before and during treatment with bortezomib to monitor your blood cell counts. You may experience a reduction in the number of:

• Platelets, which could make you more prone to bruising or bleeding without apparent injury (e.g. bleeding from the intestine, stomach, mouth and gums, or brain or liver haemorrhage)
• Red blood cells, which can cause anaemia, with symptoms such as fatigue and paleness
• White blood cells, which may increase your susceptibility to infections or flu-like symptoms.

If you are being treated with Bortezomib Glenmark for multiple myeloma, the possible side effects are listed below:
Very common side effects (may affect more than 1 in 10 people)

• Skin sensitivity, numbness, tingling or burning sensation, or pain in the hands or feet due to nerve damage.
• Decrease in the number of red and/or white blood cells (see above).
• Fever.
• Nausea or vomiting, loss of appetite.
• Constipation with or without excess intestinal gas (may be severe).
• Diarrhoea: if this occurs, it is important that you drink more fluids than usual. Your doctor may prescribe medication to control diarrhoea.
• Tiredness (fatigue), feeling of weakness.
• Muscle pain, bone pain.

Common side effects (may affect up to 1 in 10 people)

• Low blood pressure, sudden drop in blood pressure upon standing which may lead to fainting.
• Increased blood pressure.
• Reduced kidney function.
• Headache.
• General feeling of discomfort, pain, dizziness, feeling of emptiness in the head, weakness or loss of consciousness.
• Chills.
• Infections, including pneumonia, respiratory tract infections, bronchitis, fungal infection, cough with phlegm, flu-like illness.
• Herpes zoster infection (localized, including around the eyes, or disseminated throughout the body).
• Chest pain or difficulty breathing during physical activity.
• Various types of skin rash.
• Itching of the skin, skin nodules or dry skin.
• Facial redness or small capillary ruptures.
• Skin redness.
• Dehydration.
• Indigestion, bloating, burping, gas, stomach pain, intestinal or stomach bleeding.
• Changes in liver function.
• Irritation of the mouth or lips, dry mouth, mouth ulcers or sore throat.
• Weight loss, loss of taste.
• Muscle cramps, muscle spasms, muscle weakness, pain in arms and legs.
• Blurred vision.
• Infection of the outer layer of the eye and the inner surface of the eyelids (conjunctivitis).
• Nosebleeds.
• Sleep disturbances or problems, sweating, anxiety, mood changes, depressed mood, restlessness or agitation, changes in mental state, disorientation.
• Swelling of the body, including around the eyes and other body parts.

Uncommon side effects (may affect up to 1 in 100 people)

• Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate.
• Kidney failure.
• Vein inflammation, blood clots in veins and lungs.
• Blood clotting problems.
• Circulatory failure.
• Inflammation of the membrane surrounding the heart or fluid accumulation around the heart.
• Infections including urinary tract infections, influenza, herpes virus infections, ear infection and cellulitis.
• Blood in the stool, or bleeding from mucous membranes (e.g. mouth, vagina).
• Cerebrovascular disorders.
• Paralysis, seizures, falls, movement disorders, abnormal, reduced or increased sensation (touch, hearing, taste, smell), attention disorders, tremor, spasms.
• Arthritis, including inflammation of the joints of the fingers, toes and jaw.
• Lung disorders impairing oxygen supply to the body. These may include difficulty breathing, shortness of breath, laboured breathing even without physical activity, shallow or interrupted breathing, wheezing.
• Hiccups, speech disorders.
• Increased or decreased urine production (kidney damage), painful urination or presence of blood/proteins in the urine, fluid retention.
• Altered levels of consciousness, confusion, memory impairment or loss.
• Hypersensitivity.
• Hearing loss, deafness or ringing in the ears, ear discomfort.
• Hormonal changes affecting salt and water reabsorption.
• Overactivity of the thyroid gland.
• Inability to produce enough insulin or resistance to normal insulin levels.
• Irritated or inflamed eyes, excessively watery eyes, eye pain, dry eyes, eye infections, eyelid swelling (chalazion), red and swollen eyelids, eye discharge, vision disturbances, eye bleeding.
• Enlargement of lymph nodes.
• Joint or muscle stiffness, feeling of heaviness, groin pain.
• Hair loss or abnormal hair texture.
• Allergic reactions.
• Redness or pain at the injection site.
• Mouth pain.
• Infection or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestine, sometimes associated with pain or bleeding, reduced intestinal motility (including intestinal blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting with blood.
• Skin infections.
• Bacterial and viral infections.
• Dental infections.
• Pancreatitis, bile duct obstruction.
• Genital pain, erectile problems.
• Weight gain.
• Thirst.
• Hepatitis.
• Injection site or infusion device site reactions.
• Skin reactions or disorders (which may be severe and life-threatening), skin ulceration.
• Bruising, falls and injuries.
• Inflammation or bleeding of blood vessels, which may appear as small red or purple spots (usually on the legs) that may develop into large bruises on the skin or tissues.
• Benign cysts.
• A serious but reversible brain condition including seizures, high blood pressure, headache, fatigue, confusion, blindness or other vision problems.

Rare side effects (may affect up to 1 in 1,000 people)

• Heart problems including heart attack, angina.
• Severe nerve inflammation, which may cause paralysis and breathing difficulties (Guillain-Barré syndrome).
• Hot flushes.
• Change in vein colour.
• Inflammation of the spinal nerve.
• Ear problems, ear bleeding.
• Reduced activity of the thyroid gland.
• Budd-Chiari syndrome (clinical signs caused by blockage of the liver veins).
• Altered or abnormal intestinal function.
• Cerebral haemorrhage.
• Yellowing of the eyes and skin (jaundice).
• Severe allergic reaction (anaphylactic shock): signs include difficulty breathing, chest pain or tightness, and/or dizziness/weakness, severe skin itching or skin swellings, swelling of the face, lips, tongue and/or throat causing difficulty swallowing, collapse.
• Breast disorders.
• Vaginal discharge.
• Genital swelling.
• Inability to tolerate alcohol consumption.
• Wasting or loss of body mass.
• Increased appetite.
• Fistulas.
• Joint effusion.
• Cysts in the membrane covering the joints (synovial cysts).
• Fractures.
• Muscle fibre rupture leading to further complications.
• Enlarged liver, liver haemorrhage.
• Kidney tumour.
• Skin condition resembling psoriasis.
• Skin tumour.
• Pale skin.
• Increased platelets or plasma cells (a type of white blood cell) in the blood.
• Blood clotting in small blood vessels (thrombotic microangiopathy).
• Abnormal reaction to blood transfusion.
• Partial or complete loss of vision.
• Decreased libido.
• Loss of saliva.
• Protruding eyes.
• Light sensitivity.
• Rapid breathing.
• Rectal pain.
• Gallstones.
• Hernia.
• Injuries.
• Brittle or weak nails.
• Abnormal protein deposits in vital organs.
• Coma.
• Intestinal ulcers.
• Damage to multiple organs.
• Death.

If you are being treated with Bortezomib Glenmark in combination with other medicines for mantle cell lymphoma, the possible side effects are listed below:
Very common side effects (may affect more than 1 in 10 people)

• Pneumonia.
• Loss of appetite.
• Skin sensitivity, numbness, tingling or burning sensation, or pain in the hands or feet due to nerve damage.
• Nausea and vomiting.
• Diarrhoea.
• Mouth ulcers.
• Constipation.
• Muscle pain, bone pain.
• Hair loss or abnormal hair texture.
• Tiredness, feeling of weakness.
• Fever.

Common side effects (may affect up to 1 in 10 people)

• Herpes zoster infection (localized, including around the eyes, or disseminated 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 enough insulin or resistance to normal insulin levels.
• Fluid retention.
• Difficulty or problems sleeping.
• Loss of consciousness.
• Altered levels of consciousness, confusion.
• Dizziness.
• Increased heart rate, high blood pressure, sweating.
• Vision disturbances, 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 upon standing which may lead to fainting.
• Shortness of breath during physical activity.
• Cough.
• Hiccups.
• Ringing in the ears, ear discomfort.
• Intestinal or stomach bleeding.
• Indigestion.
• Stomach pain, bloating.
• Difficulty swallowing.
• Infection or inflammation of the stomach and intestine.
• Stomach pain.
• Irritation of the mouth or lips, sore throat.
• Changes in liver function.
• Itching of the skin.
• Skin redness.
• Rash.
• Muscle spasms.
• Urinary tract infection.
• Limb pain.
• Swelling of the body, including around the eyes and other body parts.
• Chills.
• Redness and pain at the injection site.
• General feeling of discomfort.
• Loss of body weight.
• Increase in body weight.

Uncommon side effects (may affect up to 1 in 100 people)

• Hepatitis.
• Severe allergic reaction (anaphylactic reaction), signs of which may include difficulty breathing, chest pain or tightness, and/or dizziness/weakness, severe skin itching or skin swellings, swelling of the face, lips, tongue and/or throat causing difficulty swallowing, collapse.
• Movement disorders, paralysis, contractions.
• Dizziness.
• Hearing loss, deafness.
• Lung disorders impairing oxygen supply to the body. These may include difficulty breathing, shortness of breath, laboured breathing even without physical activity, shallow or interrupted breathing, wheezing.
• Blood clots in the lungs.
• Yellowing of the eyes and skin (jaundice).

Rare side effects (may affect up to 1 in 1,000 people)

• Blood clotting in small blood vessels (thrombotic microangiopathy).
• Severe nerve inflammation, which may cause paralysis and breathing difficulties (Guillain-Barré syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Bortezomib Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer carton after EXP.
Store in a refrigerator (2°C–8°C).
Keep the vial in the outer packaging to protect the medicine from light.

After first opening/reconstitution/dilution
Chemical and physical in-use stability have been demonstrated for 28 days if the medicine is stored at 2°C–8°C and protected from light, for 7 days if stored at 25°C and protected from light, and for 24 hours if stored at 25°C (under normal indoor lighting conditions) in the original vial and/or in a polypropylene syringe.
From a microbiological standpoint, the product should be used immediately. If not used immediately, it is the user's responsibility to ensure storage conditions and duration, which normally do not exceed 24 hours at 2–8°C.
Regarding stability in the vial and/or in a syringe, the same storage duration applies to both diluted and undiluted solutions.
This medicine is for single use only. Any unused product and waste material must be disposed of in accordance with local regulations.

6. Package contents and other information

What Bortezomib Glenmark contains

• The active substance is bortezomib. Each vial contains 1 ml or 1.4 ml of injectable solution containing 2.5 mg per ml of bortezomib (as mannitol boronic ester).

• The other ingredients are mannitol (E421), sodium chloride, hydrochloric acid and water for injections.

• For intravenous use: After dilution, 1 ml of intravenous injection solution contains 1 mg of bortezomib.

• For subcutaneous use: 1 ml of subcutaneous injection solution contains 2.5 mg of bortezomib.

Description of the appearance of Bortezomib Glenmark and contents of the pack
Bortezomib Glenmark is a clear, colourless to pale yellow solution.
Clear glass vial with a rubber stopper and red aluminium cap with a flip-off seal, containing 1 ml of solution.
Clear glass vial with a rubber stopper and blue aluminium cap with a flip-off seal, containing 1.4 ml of solution.

Packs
1 x 1 ml vial
1 x 1.4 ml vial
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
14078 Prague 4
Czech Republic

Manufacturer
Synoptis Industrial Sp. Z.o.o.
ul. Rabowicka 15, Swarzędz,
wielkopolskie, 62-020
Poland

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

The following information is intended exclusively for physicians or healthcare professionals:
Note: Bortezomib Glenmark is a cytotoxic agent. Therefore, particular care must be taken during handling and preparation. It is recommended to wear gloves and other protective clothing to prevent skin contact.
Pregnant personnel must not handle this medicinal product.
DUE TO THE ABSENCE OF ANY TYPE OF PRESERVATIVE, ASEPTIC TECHNIQUE MUST BE FOLLOWED DURING THE HANDLING OF BORTEZOMIB.

1. PREPARATION FOR INTRAVENOUS INJECTION

1.1 Preparation of the 2.5 mg/1 ml vial: add 1.5 ml of injectable sodium chloride solution 9 mg/ml (0.9%) to the vial containing bortezomib.
Preparation of the 3.5 mg/1.4 ml vial: add 2.1 ml of injectable sodium chloride solution 9 mg/ml (0.9%) to the vial containing bortezomib.
The resulting solution has a concentration of 1 mg/ml. The solution will be clear and colourless to pale yellow, with a final pH between 4 and 7. There is no need to check the pH of the solution.

1.2 The solution must be inspected visually before administration to check for the presence of particulate matter or discoloration. If particulate matter or discoloration is observed, the solution must be discarded. Ensure that the correct dose is administered intravenously (1 mg/ml).

1.3 Chemical and physical in-use stability has been demonstrated for 28 days if the medicinal product is stored at 2 °C–8 °C and protected from light, for 7 days if stored at 25 °C and protected from light, and for 24 hours if stored at 25 °C (under normal indoor lighting conditions) in the original vial and/or in a polypropylene syringe.
From a microbiological standpoint, the product should be used immediately. If not used immediately, it is the user's responsibility to ensure that storage conditions and duration do not exceed 24 hours at 2–8 °C.

During preparation for administration and during the administration itself, there is no need to protect the medicinal product from light.

2. ADMINISTRATION

• After dilution, withdraw the appropriate volume of the diluted solution according to the dose calculated based on the patient's body surface area.
• Confirm the dose and concentration in the syringe before use (check that the syringe is labeled for intravenous administration).
• Inject the solution as an intravenous bolus over 3 to 5 seconds through a peripheral or central intravenous catheter.
• Flush the intravenous catheter (peripheral or central) with sterile sodium chloride 9 mg/ml (0.9%) solution.

Bortezomib Glenmark 2.5 mg/ml solution for injection
FOR SUBCUTANEOUS OR INTRAVENOUS USE ONLY.
Do not administer by any other route.
Intrathecal administration has resulted in deaths.

3. DISPOSAL

The vial is for single use only, and any remaining solution must be discarded.
Unused medicine and waste material arising from this medicine must be disposed of in accordance
with local regulations governing cytotoxic agents.
The following information is intended for physicians or healthcare professionals only:
1 PREPARATION FOR SUBCUTANEOUS INJECTION
Pregnant personnel must not handle this medicine.
Note: Bortezomib is a cytotoxic agent. Therefore, particular care must be taken during handling and
preparation. It is recommended to wear gloves and other protective clothing to prevent skin contact.
DUE TO THE ABSENCE OF ANY KIND OF PRESERVATIVE, ASEPTIC TECHNIQUE
MUST BE OBSERVED DURING HANDLING OF BORTEZOMIB.
1.1 Bortezomib Glenmark for injection is ready to use.
The concentration of the solution is 2.5 mg/ml. The solution is clear and colourless to pale yellow, with a final pH between 4.0 and 6.5. The pH of the solution does not need to be checked.
1.2 The solution should be inspected visually prior to administration for the presence of particulate matter or discoloration. If particulate matter or discoloration is observed, the solution must be discarded. Ensure that the correct dose is administered subcutaneously (2.5 mg/ml).
1.3 Chemical and physical in-use stability has been demonstrated for 28 days if the medicine is stored at 2 °C–8 °C and protected from light, for 7 days if stored at 25 °C and protected from light, and for 24 hours if stored at 25 °C (under normal indoor lighting conditions) in the original vial and/or in a polypropylene syringe.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for the storage conditions and duration lies with the user and generally should not exceed 24 hours at 2–8 °C.
1.4 During preparation for administration and during administration itself, protection of the medicine from light is not required.

2. ADMINISTRATION

• Withdraw the appropriate volume of solution according to the dose calculated based on the patient's body surface area.
• Confirm the dose and concentration in the syringe before use (check that the syringe is labeled for subcutaneous administration).
• Inject the solution subcutaneously at an angle of 45–90°.
• The solution is administered subcutaneously in the thighs (right or left) or in the abdomen (right or left).
• For subsequent administrations, rotate the injection site.
• If local reactions occur at the injection site following subcutaneous administration of bortezomib, a lower concentration of bortezomib solution may be administered (1 mg/ml instead of 2.5 mg/ml), or intravenous injection is recommended.

Bortezomib Glenmark 2.5 mg/ml solution for injection
FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Do not administer by other routes.
Intrathecal administration has resulted in deaths.

3. DISPOSAL

The vial is for single use only, and any remaining solution must be discarded.
Unused medicine and waste materials resulting from this medicine must be disposed of in accordance with local regulations for cytotoxic agents.