Bortezomib Adamed

Patient Information Leaflet: User Information

Bortezomib Adamed 3.5 mg, powder for solution for intravenous injection

Bortezomib

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any questions.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Bortezomib Adamed contains the active substance bortezomib, which is a so-called "proteasome inhibitor". Proteasomes play a crucial role in controlling cell function and development. By disrupting their function, bortezomib can lead to the death of cancer cells.
Bortezomib Adamed is used to treat multiple myeloma (a type of bone marrow cancer) in patients over 18 years of age:

• as a single drug or in combination with other drugs: pegylated liposomal doxorubicin or dexamethasone in patients whose disease has progressed after at least one previous treatment and for whom hematopoietic stem cell transplantation was not successful or not possible;
• in combination with melphalan and prednisone in patients who have not been previously treated and do not qualify for high-dose chemotherapy with hematopoietic stem cell transplantation.
• in combination with dexamethasone or dexamethasone with thalidomide in patients who have not been previously treated and qualify for high-dose chemotherapy with hematopoietic stem cell transplantation (induction treatment).

Bortezomib Adamed is used to treat mantle cell lymphoma (a type of lymph node cancer) in patients over 18 years of age in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients who have not been previously treated and do not qualify for hematopoietic stem cell transplantation.

2. Important information before using Bortezomib Adamed

When not to use Bortezomib Adamed

• -if the patient is allergic to bortezomib, boron, or any of the other ingredients of this medicine (listed in section 6);
• -if the patient has severe lung or heart disease.

Warnings and precautions

Tell your doctor if you have:

• a low number of red or white blood cells;
• bleeding disorders and (or) low platelet count;
• diarrhea, constipation, nausea, or vomiting;
• a history of fainting, dizziness, and lightheadedness;
• kidney disease;
• moderate to severe liver function disorders;
• a history of numbness, tingling, and pain in the hands and feet (symptoms of neuropathy);
• heart disease or blood pressure problems;
• shortness of breath or cough;
• seizures;
• shingles (around the eyes or widespread on the body);
• symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss of vision, and shortness of breath;
• memory loss, thinking disorders, difficulty walking, or vision loss. These may be symptoms of a severe brain infection, and your doctor may recommend further tests and observation.

The patient must have regular blood tests before and during treatment with Bortezomib Adamed to regularly check the number of blood cells.
If the patient is taking Bortezomib Adamed in combination with rituximab, tell your doctor:

• if you suspect or have had hepatitis B virus infection in the past. In a few cases, patients who had hepatitis B virus infection had recurring episodes of hepatitis, which could be fatal. If you have a history of hepatitis B virus infection, your doctor will closely monitor you for signs of active hepatitis B virus infection.

Before starting treatment with Bortezomib Adamed, read the package leaflets of all medicines you are taking during treatment to get information about them.
If you are taking thalidomide, you must exclude pregnancy and then use effective contraception (see section Pregnancy and breastfeeding).

Children and adolescents

Bortezomib Adamed should not be used in children and adolescents, as it is not known how the medicine works in this age group.

Other medicines and Bortezomib Adamed

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 for the treatment of epilepsy;
• St. John's Wort (Hypericum perforatum) for the treatment of depression and other conditions;
• oral antidiabetic drugs.

Pregnancy and breastfeeding

Bortezomib Adamed should not be used during pregnancy unless absolutely necessary.
Both men and women receiving Bortezomib Adamed must use effective contraception during and for 3 months after completing treatment. If, despite the use of these methods, the patient becomes pregnant, the doctor should be informed immediately.
Women should not breastfeed during treatment with Bortezomib Adamed.
It is necessary to discuss with the doctor the issue of safe return to breastfeeding after completing treatment in the patient.
Thalidomide causes birth defects and fetal death. When Bortezomib Adamed is used in combination with thalidomide, patients must follow the "Thalidomide Pregnancy Prevention Program" (see thalidomide package leaflet).

Driving and using machines

Bortezomib Adamed may cause fatigue, dizziness, fainting, and blurred vision. If these symptoms occur, do not drive or operate tools or equipment; even if symptoms do not occur, caution should still be exercised.

3. How to use Bortezomib Adamed

Your doctor will adjust the appropriate dose of Bortezomib Adamed based on the patient's height and weight (body surface area). The most commonly used initial dose of Bortezomib Adamed is 1.3 mg/m2 body surface area, administered twice a week.
The doctor may change the dose and total number of treatment cycles depending on the patient's response to treatment, the occurrence of side effects, and additional diseases (e.g., liver disease).
Relapsed multiple myeloma
If the product Bortezomib Adamed is administered as a single drug, the patient will receive 4 doses of Bortezomib Adamed intravenously or subcutaneously on days: 1, 4, 8, and 11, followed by a 10-day break in treatment. The described 21-day period (3 weeks) is considered one treatment cycle.
The patient will receive up to 8 cycles (24 weeks).
The patient may also receive Bortezomib Adamed in combination with pegylated liposomal doxorubicin or dexamethasone.

• When Bortezomib Adamed is administered in combination with pegylated liposomal doxorubicin, the patient will receive Bortezomib Adamed intravenously or subcutaneously during a 21-day treatment cycle, and pegylated liposomal doxorubicin will be administered at a dose of 30 mg/m2 in an intravenous infusion on day 4 of the 21-day cycle.
• The patient may receive up to 8 cycles (24 weeks).
• When Bortezomib Adamed is administered in combination with dexamethasone, the patient will receive Bortezomib Adamed intravenously or subcutaneously during a 21-day treatment cycle, and dexamethasone will be administered orally at a dose of 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the Bortezomib Adamed 21-day cycle. The patient may receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma
If the patient has not been previously treated for multiple myeloma and the patientdoes not qualify for hematopoietic stem cell transplantation, they will receive Bortezomib Adamed in combination with melphalan and prednisone.
In this case, the treatment cycle lasts 42 days (6 weeks). The patient will receive 9 cycles (54 weeks).

• During cycles 1-4, Bortezomib Adamed is administered twice a week, on days: 1, 4, 8, 11, 22, 25, 29, and 32.
• 22, 25, 29, and 32.
• During cycles 5-9, Bortezomib Adamed is administered once a week, on days: 1, 8, 22, and 29. Both 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.
• 29. Both 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 the patient has not been previously treated for multiple myeloma and the patientqualifies for hematopoietic stem cell transplantation, they will receive Bortezomib Adamed intravenously in combination with dexamethasone or dexamethasone with thalidomide for induction treatment.
When Bortezomib Adamed is administered with dexamethasone, the patient will receive Bortezomib Adamed intravenously in a 21-day cycle, and dexamethasone will be administered orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 21-day Bortezomib Adamed cycle. The patient will receive up to 4 cycles (12 weeks).

Previously untreated mantle cell lymphoma
If the patient has not been previously treated for mantle cell lymphoma, they will receive Bortezomib Adamed intravenously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone. Bortezomib Adamed is administered intravenously on days 1, 4, 8, and 11, followed by a "rest period" without medication administration. One treatment cycle lasts 21 days (3 weeks). The patient will receive up to 8 cycles (24 weeks).

How Bortezomib Adamed is administered

This medicine is administered intravenously or subcutaneously. Bortezomib Adamed will be administered by a healthcare professional with experience in the use of cytotoxic drugs.
The powder of Bortezomib Adamed must be dissolved before administration. The preparation of the medicine is carried out by a healthcare professional. The resulting solution is then injected either rapidly intravenously, over 3 to 5 seconds, or subcutaneously. The subcutaneous injection is administered into the thigh or abdomen.

Use of a higher than recommended dose of Bortezomib Adamed

Since this medicine is administered by a doctor or nurse, it is unlikely that the patient will receive too high a dose of the medicine.
If this happens exceptionally, the doctor will monitor the patient for side effects.

4. Possible side effects

Like all medicines, Bortezomib Adamed can cause side effects, although not everybody gets them.
Some of these side effects may be serious.
If you are receiving Bortezomib Adamed for multiple myeloma or mantle cell lymphoma, tell your doctor immediately if you experience any of the following symptoms:

• muscle cramps, muscle weakness;
• confusion, loss of vision, blindness, seizures, headaches;
• shortness of breath, swelling of the feet or changes in heart rhythm, high blood pressure, fatigue, fainting;
• cough and difficulty breathing or pressure in the chest.

Treatment with Bortezomib Adamed can very often cause a decrease in the number of red and white blood cells and platelets in the patient's blood. Therefore, the patient must have regular blood tests before and during treatment with Bortezomib Adamed to regularly check the number of blood cells. The patient may experience a decrease in:

• platelets, which can lead to a tendency to bruise or bleed without injury (e.g., gastrointestinal bleeding, bleeding from the mouth, gums, or nose);
• red blood cells, which can lead to anemia, with symptoms such as fatigue and paleness;
• white blood cells, which can lead to increased susceptibility to infections or flu-like symptoms.

If you are receiving Bortezomib Adamed for multiple myeloma, you may experience the following side effects:

Very common side effects (may affect more than 1 in 10 people):

• allergic reactions, numbness, tingling, or burning sensation of the skin, pain in the hands or feet caused by nerve damage;
• decrease in the number of red and (or) white blood cells (see above);
• fever;
• nausea or vomiting, loss of appetite;
• constipation occurring with or without bloating (symptoms may be severe);
• diarrhea: if it occurs, the patient should drink more water than usual, the doctor may recommend taking additional medicines to control diarrhea;
• fatigue, feeling of weakness;
• muscle pain, bone pain.

Common side effects (may affect less than 1 in 10 people):

• low blood pressure, sudden drop in blood pressure when standing up, which can lead to fainting;
• high blood pressure;
• decreased kidney function;
• headache;
• general feeling of being unwell, pain, dizziness, lightheadedness, feeling of weakness or loss of consciousness;
• chills;
• infections, including pneumonia, respiratory tract infections, bronchitis, fungal infections, cough with sputum production, flu-like symptoms;
• shingles (localized, e.g., around the eyes or widespread on the body);
• chest pain, shortness of breath during exercise;
• various types of rash;
• itching, skin rash, or dry skin;
• flushing of the face or broken blood vessels;
• redness of the skin;
• dehydration;
• heartburn, bloating, belching, gas, abdominal pain, gastrointestinal bleeding;
• liver function disorders;
• mouth ulcers or mouth sores, dry mouth, throat pain;
• weight loss, loss of taste;
• muscle cramps, muscle weakness, bone pain;
• blurred vision;
• conjunctivitis;
• nosebleeds;
• difficulty sleeping, sweating, anxiety, mood swings, depression, restlessness, or agitation, changes in mental state, disorientation;
• swelling, including around the eyes and other parts of the body.

Uncommon side effects (may affect less than 1 in 100 people):

• heart failure, heart attack, chest pain, discomfort in the chest, rapid or slow heart rate;
• kidney failure;
• vein inflammation, blood clots in veins and lungs;
• blood clotting disorders;
• circulatory failure;
• pericarditis (inflammation of the outer layer of the heart) or fluid in the pericardium;
• infections, including urinary tract infections, flu, herpes, ear and soft tissue infections;
• bleeding from the gastrointestinal tract or stomach;
• nerve disorders;
• paralysis, seizures, falls, movement disorders, abnormal, changed, or weakened sensation (touch, hearing, taste, smell), attention disorders, tremors, twitching;
• arthritis, including joint pain in the fingers, toes, and jaw;
• lung disorders that make breathing difficult. Some of these include: difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or cessation of breathing, wheezing;
• blood clots in the lungs;
• jaundice (yellowing of the skin and eyes);
• sty (inflammation of the eyelid), redness, and swelling of the eyelid.

Rare side effects (may affect less than 1 in 1000 people):

• heart disease, including heart attack, angina pectoris;
• flushing;
• discoloration of the veins;
• spinal cord inflammation;
• ear disorders, ear bleeding;
• hypothyroidism;
• Budd-Chiari syndrome (clinical symptoms caused by blockage of liver veins);
• abnormal or changed bowel function;
• brain bleeding;
• jaundice (yellowing of the skin and eyes);
• severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, pain or pressure in the chest, and (or) feeling of dizziness or fainting, severe itching of the skin or hives on the skin, swelling of the face, lips, tongue, and (or) throat, which can cause difficulty breathing and swallowing, collapse;
• breast disorders;
• vaginal ulcers;
• genital swelling;
• alcohol intolerance;
• weight loss or gain;
• increased appetite;
• fistula;
• joint effusion;
• ganglion cyst (a type of lump that forms under the skin);
• bone fractures;
• muscle fiber breakdown leading to further complications;
• liver swelling, liver bleeding;
• kidney cancer;
• a skin condition similar to psoriasis;
• skin cancer;
• pale skin;
• increased platelet count or plasma cells (a type of white blood cell);
• blood clots in small blood vessels (microangiopathic thrombosis);
• abnormal reaction to blood transfusion;
• partial or complete loss of vision;
• decreased libido;
• excessive salivation;
• exophthalmos;
• photosensitivity;
• increased respiratory rate;
• rectal pain;
• gallstones;
• hernia;
• injuries;
• brittle or weak nails;
• abnormal protein deposition in organs;
• coma;
• intestinal ulcers;
• multi-organ failure;
• death
• severe nerve inflammation, which can cause paralysis and breathing difficulties (Guillain-Barré syndrome).

If you are receiving Bortezomib Adamed in combination with other medicines for mantle cell lymphoma, you may experience the following side effects:

Very common side effects (may affect more than 1 in 10 people):

• pneumonia;
• loss of appetite;
• allergic reactions, numbness, tingling, or burning sensation of the skin, pain in the hands or feet caused by nerve damage;
• nausea or vomiting;
• diarrhea;
• mouth ulcers;
• constipation;
• muscle pain, bone pain;
• hair loss and abnormal hair structure;
• fatigue, feeling of weakness;
• fever.

Common side effects (may affect less than 1 in 10 people):

• shingles (localized, e.g., around the eyes or widespread on the body);
• herpes virus infection;
• bacterial and viral infections;
• respiratory tract infections, bronchitis, wet cough, flu-like symptoms;
• fungal infections;
• allergic reactions;
• decreased insulin production or resistance to normal insulin levels;
• fluid retention;
• sleep disorders;
• loss of consciousness;
• changed level of consciousness, confusion;
• dizziness;
• rapid heartbeat, high blood pressure, sweating;
• abnormal vision, blurred vision;
• heart failure, heart attack, chest pain, discomfort in the chest, rapid or slow heart rate;
• high or low blood pressure;
• sudden drop in blood pressure when changing body position, which can lead to fainting;
• shortness of breath during exercise;
• cough;
• hiccups;
• ringing in the ears, discomfort in the ears;
• gastrointestinal bleeding or stomach bleeding;
• heartburn;
• mouth pain, throat pain;
• abdominal pain, bloating;
• difficulty swallowing;
• infection or inflammation of the stomach or intestines;
• abdominal pain;
• mouth ulcers or mouth sores, throat pain, mouth inflammation;
• liver function changes;
• itching;
• redness of the skin;
• rash;
• muscle cramps;
• muscle pain, bone pain;
• urinary tract infections;
• limb pain;
• swelling, including around the eyes and other parts of the body.

Uncommon side effects (may affect less than 1 in 100 people)

• liver inflammation;
• severe allergic reaction (anaphylactic reaction), which can cause symptoms such as: difficulty breathing, pain or pressure in the chest, and (or) feeling of dizziness or fainting, severe itching of the skin or hives on the skin, swelling of the face, lips, tongue, and (or) throat, which can cause difficulty breathing and swallowing, collapse;
• movement disorders, paralysis, muscle cramps, muscle twitching;
• dizziness;
• hearing loss, deafness;
• lung disorders that make breathing difficult. Some of these include: difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or cessation of breathing, wheezing;
• blood clots in the lungs;
• jaundice (yellowing of the skin and eyes);
• sty (inflammation of the eyelid), redness, and swelling of the eyelid.

Rare side effects (may affect less than 1 in 1000 people)

• blood clots in small blood vessels (microangiopathic thrombosis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bortezomib Adamed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton, after "EXP".
Store the vial in the outer carton to protect from light.
No special precautions for storage temperature of the medicinal product.
Reconstituted solution
Chemical and physical stability of the medicinal product has been demonstrated for 8 hours, stored at 25°C, 60% RH, in the original vial and/or polypropylene syringe.
From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, the storage times and conditions are the responsibility of the user and should not exceed 24 hours at 2-8°C, unless reconstitution/reconstitution has taken place in controlled aseptic conditions.
Bortezomib Adamed is for single use only. Any unused solution or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Bortezomib Adamed contains

• The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as a mannitol and boric acid ester).
• The other ingredients are: mannitol (E 421).

Solution for injection:
After reconstitution, 1 ml of solution for injection contains 1 mg of bortezomib.
Solution for subcutaneous injection:
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg of bortezomib.

What Bortezomib Adamed looks like and contents of the pack

Bortezomib Adamed powder for solution for injection is a white or off-white lyophilized powder or powder.
Bortezomib Adamed is packed in a 10 ml glass vial, type I, with a bromobutyl rubber stopper and an aluminum seal with a plastic flip-off cap, in a cardboard box.
The pack contains 1 single-use vial.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Synthon s.r.o. Blansko
Brnenska 32/c.p.597, 678 01 Blansko,
Czech Republic
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet:

• 04.2021

The following information is intended for healthcare professionals only:

1. PREPARATION OF THE INTRAVENOUS INJECTION SOLUTION

Caution: Bortezomib Adamed is a cytotoxic product. When handling the product and preparing it for use, caution should be exercised. To protect against skin contact with the product, gloves and other protective clothing are recommended.
BECAUSE Bortezomib Adamed DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED WHEN HANDLING THE PRODUCT.

• 1.1. Preparation of the 3.5 mg vial: add 3.5 mlof sterile, 9 mg/ml (0.9%) sodium chloride injection to the vial containing Bortezomib Adamed powder. Reconstitution of the lyophilized powder takes less than 2 minutes.

The resulting solution will have a concentration of 1 mg/ml. After reconstitution, the solution will be clear and colorless, with a pH between 4 and 7. There is no need to check the pH of the solution.

• 1.2. Before administration, visually inspect the solution for particulate matter and discoloration. If particulate matter or discoloration is observed, the solution should be discarded. Check the concentration on the vial to ensure that the correct dose is administered intravenously (1 mg/ml).
• 1.3. The reconstituted solution is preservative-free and should be used immediately after preparation. However, the chemical and physical stability of the reconstituted solution has been demonstrated for 8 hours when stored at 25°C, 60% RH, in the original vial and/or polypropylene syringe. The total storage time of the solution in the syringe before administration should not exceed 8 hours. If the reconstituted solution is not administered immediately, the responsibility for the storage time and conditions before administration lies with the user and should not exceed 24 hours at 2-8°C, unless reconstitution/reconstitution has taken place in controlled aseptic conditions.

There is no need to protect the reconstituted solution from light.

2. ADMINISTRATION

• After reconstitution, withdraw the appropriate dose of the reconstituted solution based on the patient's body surface area.
• Before administration, confirm the dose and concentration of the solution in the syringe (check that the syringe is labeled for intravenous administration).
• Administer the solution as an intravenous bolus injection over 3 to 5 seconds.
• Flush the intravenous administration set with a small amount of sterile, 9 mg/ml (0.9%) sodium chloride injection.

3. DISPOSAL OF THE PRODUCT

The vial is for single use only and any unused solution should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.

The following information is intended for healthcare professionals only:

1. PREPARATION OF THE SUBCUTANEOUS INJECTION SOLUTION

Caution: Bortezomib Adamed is a cytotoxic product. When handling the product and preparing it for use, caution should be exercised. To protect against skin contact with the product, gloves and other protective clothing are recommended.
BECAUSE Bortezomib Adamed DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED WHEN HANDLING THE PRODUCT.

• 1.1. Preparation of the 3.5 mg vial: add 1.4 mlof sterile, 9 mg/ml (0.9%) sodium chloride injection to the vial containing Bortezomib Adamed powder. Reconstitution of the lyophilized powder takes less than 2 minutes.

The resulting solution will have a concentration of 2.5 mg/ml. After reconstitution, the solution will be clear and colorless, with a pH between 4 and 7. There is no need to check the pH of the solution.

• 1.2. Before administration, visually inspect the solution for particulate matter and discoloration. If particulate matter or discoloration is observed, the solution should be discarded. Ensure that the correct dose is administered subcutaneously (2.5 mg/ml).
• 1.3. The reconstituted solution is preservative-free and should be used immediately after preparation. However, the chemical and physical stability of the reconstituted solution has been demonstrated for 8 hours when stored at 25°C, 60% RH, in the original vial and/or polypropylene syringe. The total storage time of the solution in the syringe before administration should not exceed 8 hours. If the reconstituted solution is not administered immediately, the responsibility for the storage time and conditions before administration lies with the user and should not exceed 24 hours at 2-8°C, unless reconstitution/reconstitution has taken place in controlled aseptic conditions.

There is no need to protect the reconstituted solution from light.

2. ADMINISTRATION

• After reconstitution, withdraw the appropriate dose of the reconstituted solution based on the patient's body surface area.
• Before administration, confirm the dose and concentration of the solution in the syringe (check that the syringe is labeled for subcutaneous administration).
• Administer the solution subcutaneously at an angle of 45-90°.
• Administer the reconstituted solution subcutaneously into the thigh (right or left) or abdomen (right or left side).
• Rotate the injection sites.
• If a local reaction occurs after subcutaneous injection of Bortezomib Adamed, it is recommended to administer the subcutaneous solution of Bortezomib Adamed at a lower concentration (dilution to 1 mg/ml instead of 2.5 mg/ml) or to change to intravenous administration.

Bortezomib Adamed powder for solution for injection 3.5 mg

ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY. DO NOT ADMINISTER BY ANY OTHER ROUTE. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.

3. DISPOSAL OF THE PRODUCT

The vial is for single use only and any unused solution should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.