Bortezomib Krka

Package Leaflet: Information for the User

Bortezomib Krka, 1 mg, Powder for Solution for Injection

Bortezomib

Read All of This Leaflet Carefully Before You Start Using This Medicine.

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

Contents of the Pack:

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

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

Bortezomib Krka contains the active substance bortezomib, which is a so-called "proteasome inhibitor". Proteasomes play an important role in controlling cell functions and development. By disrupting their function, bortezomib can lead to the death of cancer cells.

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

• as a single medicine or in combination with other medicines: pegylated liposomal doxorubicin or dexamethasone in patients whose disease has progressed after receiving at least one prior therapy and who have undergone a failed or ineligible hematopoietic stem cell transplant;
• in combination with melphalan and prednisone in patients who have not received prior therapy and are not eligible for high-dose chemotherapy with hematopoietic stem cell transplantation;
• in combination with dexamethasone or dexamethasone with thalidomide in patients who have not received prior therapy and are eligible for high-dose chemotherapy with hematopoietic stem cell transplantation (induction therapy). Bortezomib Krka is also used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients over 18 years of age in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients who have not received prior therapy and are not eligible for hematopoietic stem cell transplantation.

2. Important information before using Bortezomib Krka

When Not to Use Bortezomib Krka

• 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 diseases.

Warnings and Precautions

Tell your doctor if you:

• have a low number of red or white blood cells;
• have bleeding disorders and (or) a low platelet count;
• have diarrhea, constipation, nausea, or vomiting;
• have had fainting, dizziness, or lightheadedness in the past;
• have kidney disease;
• have moderate to severe liver function disorders;
• have had numbness, tingling, or pain in your hands or feet (symptoms of neuropathy);
• have heart disease or blood pressure problems;
• have shortness of breath or cough;
• have had seizures;
• have had shingles (around the eyes or widespread);
• have symptoms of tumor lysis syndrome, such as muscle cramps, weakness, confusion, or vision changes and shortness of breath;
• have memory loss, difficulty thinking, difficulty walking, or loss of vision. These may be symptoms of a serious brain infection. Your doctor may recommend further tests and monitoring. You will need to have regular blood tests before and during treatment with Bortezomib Krka to check your blood cell count. If you have mantle cell lymphoma and are receiving rituximab with Bortezomib Krka, tell your doctor:
• if you suspect you have a hepatitis virus infection or have had it in the past. In a few cases, patients who have had hepatitis B virus infection may have a recurrence of the infection, which can be fatal. Patients with a history of hepatitis B virus infection will be closely monitored by their doctor for signs of active hepatitis B. Before starting treatment with Bortezomib Krka, read the package leaflets of all other medicines you are taking to get information about them. If you are taking thalidomide, you must exclude pregnancy and use effective contraception (see below "Pregnancy and Breastfeeding").

Children and Adolescents

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

Other Medicines and Bortezomib Krka

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

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

• ketokonazole, 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 medicines.

Pregnancy and Breastfeeding

Bortezomib Krka should not be used during pregnancy unless it is absolutely necessary.

Both men and women receiving Bortezomib Krka must use effective contraception during treatment and for 3 months after treatment. If you become pregnant despite using contraception, tell your doctor immediately.

Do not breastfeed while using Bortezomib Krka. Discuss with your doctor when it is safe to resume breastfeeding after treatment.

Thalidomide causes birth defects and fetal death. When Bortezomib Krka is used in combination with thalidomide, patients must follow the "Thalidomide Pregnancy Prevention Program" (see the thalidomide package leaflet).

Driving and Using Machines

Bortezomib Krka may cause fatigue, dizziness, fainting, and blurred vision. Do not drive or operate tools or machines if you experience these symptoms; even if you do not experience symptoms, be cautious.

3. How to Use Bortezomib Krka

Your doctor will adjust the dose of Bortezomib Krka based on your body surface area.

The most commonly used starting dose of Bortezomib Krka is 1.3 mg/m² administered twice a week.

Your doctor may change the dose and total number of treatment cycles based on your response to treatment, side effects, and other conditions (e.g., liver function).

Relapsed Multiple Myeloma

If Bortezomib Krka is administered as a single medicine, you will receive 4 doses of Bortezomib Krka intravenously on days 1, 4, 8, and 11, followed by a 10-day rest period. This 21-day period (3 weeks) is considered one treatment cycle. You may receive up to 8 cycles (24 weeks).

You may also receive Bortezomib Krka in combination with pegylated liposomal doxorubicin or dexamethasone.

When Bortezomib Krka is administered in combination with pegylated liposomal doxorubicin, you will receive Bortezomib Krka intravenously during a 21-day treatment cycle, and pegylated liposomal doxorubicin will be administered at a dose of 30 mg/m² as an intravenous infusion after Bortezomib Krka administration on day 4 of the 21-day cycle.

You may receive up to 8 cycles (24 weeks).

When Bortezomib Krka is administered in combination with dexamethasone, you will receive Bortezomib Krka intravenously 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 Krka 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 youdo not qualify for hematopoietic stem cell transplantation, you will receive Bortezomib Krka in combination with melphalan and prednisone.

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

• During cycles 1-4, Bortezomib Krka will be administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• During cycles 5-9, Bortezomib Krka will be administered once a week on days 1, 8, 22, and 29.
• Melphalan (9 mg/m²) and prednisone (60 mg/m²) will be administered orally on days 1, 2, 3, and 4 of the first week of each cycle.
• If you have not been treated for multiple myeloma before and youqualify for hematopoietic stem cell transplantation, you will receive Bortezomib Krka intravenously in combination with dexamethasone or dexamethasone with thalidomide as induction therapy.

When Bortezomib Krka is administered with dexamethasone, you will receive Bortezomib Krka intravenously during a 21-day treatment 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 treatment cycle.

You may receive up to 4 cycles (12 weeks).

When Bortezomib Krka is administered with dexamethasone and thalidomide, the treatment cycle lasts 28 days (4 weeks). Dexamethasone will be administered orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day treatment cycle, and thalidomide will be administered orally once daily at a dose of 50 mg up to day 14 of the first cycle, and if the dose is tolerated, it may be increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle.

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 Krka intravenously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib Krka will be administered intravenously on days 1, 4, 8, and 11, followed by a rest period. One treatment cycle lasts 21 days (3 weeks). You may receive up to 8 cycles (24 weeks).

The following medicines will be administered as intravenous infusions on day 1 of each 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 will be administered orally at a dose of 100 mg/m² on days 1, 2, 3, 4, and 5 of the Bortezomib Krka treatment cycle.

How Bortezomib Krka is Administered

This medicine is for intravenous use only. Bortezomib Krka will be administered by a healthcare professional with experience in the use of cytotoxic medicines.

The powder of Bortezomib Krka must be reconstituted before administration. Reconstitution is performed by a healthcare professional.

The reconstituted solution is then administered intravenously over 3 to 5 seconds.

Overdose

Since this medicine is administered by a doctor or nurse, it is unlikely that you will receive too much medicine.

If this happens, your doctor will monitor you for side effects.

4. Possible Side Effects

Like all medicines, Bortezomib Krka can cause side effects, although not everybody gets them.

Some of these side effects can be serious.

If you are receiving Bortezomib Krka 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 chest pressure. Treatment with Bortezomib Krka can very often cause a decrease in the number of red and white blood cells and platelets in your blood. Therefore, you will need to have regular blood tests before and during treatment with Bortezomib Krka to check your blood cell count.
• decrease in platelet count, which may cause bruising or bleeding that is not due to injury (e.g., bleeding from the gut, stomach, mouth, and gums, or bleeding in the brain or liver);

decrease in red blood cell count, which may cause anemia, with symptoms such as fatigue and paleness;

• decrease in white blood cell count, which may cause increased susceptibility to infections or flu-like symptoms.

If you are receiving Bortezomib Krka 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 hands or feet due to nerve damage;
• decrease in red and (or) white blood cell count (see above);
• fever;
• nausea or vomiting, loss of appetite;
• constipation occurring with or without bloating (symptoms may be severe);
• diarrhea: if this occurs, you should drink more water than usual. Your doctor may recommend taking additional medicines to control diarrhea;
• fatigue, feeling weak;
• muscle pain, bone pain.

Common Side Effects (May Affect Up to 1 in 10 People):

• low blood pressure, sudden drop in blood pressure when standing up, which may cause fainting;
• high blood pressure;
• decreased kidney function;
• headache;
• general feeling of being unwell, pain, dizziness, lightheadedness, feeling weak or loss of consciousness;
• chills;
• infections, including pneumonia, respiratory tract infections, bronchitis, fungal infections, cough with sputum production, flu-like symptoms;
• shingles (localized around the eyes or widespread);
• chest pain, shortness of breath during exercise;
• various types of rash;
• itching, skin lumps, 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 or lip pain, dry mouth, mouth ulcers, or throat pain;
• weight loss, loss of taste;
• muscle spasms, muscle weakness, muscle pain;
• blurred vision;
• infection of the outer layer of the eye and the mucous membrane lining the eyelid (conjunctivitis);
• nosebleeds;
• difficulty sleeping, excessive sweating, anxiety, mood swings, depression, restlessness, or agitation;
• swelling, including around the eyes and other parts of the body.

Uncommon Side Effects (May Affect Up to 1 in 100 People):

• heart failure, heart attack, chest pain, feeling of discomfort in the chest, rapid or slow heart rate;
• kidney failure;
• vein inflammation, blood clots in veins and lungs;
• blood clotting disorders;
• circulatory failure;
• inflammation of the sac surrounding the heart (pericarditis) or fluid in the pericardium;
• infections, including urinary tract infections, flu, viral infections, ear infections, and infections of the connective tissue;
• blood in the stool, bleeding from mucous membranes, e.g., from the mouth, vagina;
• brain vessel disorders;
• paralysis, seizures, falls, movement disorders, abnormal, changed, or weakened sensation (touch, hearing, taste, smell), attention disorders, tremors, muscle twitching;
• joint inflammation, including joint inflammation of the fingers, toes, and jaw;
• lung disorders making breathing difficult. Some of these include difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or cessation of breathing, wheezing;
• hiccups, speech disorders;
• increased or decreased urine production (due to kidney damage), pain when urinating, or blood (and/or) protein in the urine, fluid retention;
• disorders of consciousness, confusion, worsening or loss of memory;
• allergic reactions;
• hearing loss, deafness, ringing, or discomfort in the ears;
• hormonal disorders that can affect salt and water absorption;
• hyperthyroidism;
• insulin deficiency or resistance to normal insulin levels;
• eye irritation or inflammation, excessive tearing, eye pain, dry eyes, eye infections, stye (hordeolum), redness and swelling of the eyelids, eye discharge, vision disorders, bleeding in the eyes;
• lymph node enlargement;
• joint stiffness or muscle stiffness, feeling of heaviness, groin pain;
• hair loss and abnormal hair structure;
• allergic reactions;
• redness or pain at the injection site;
• mouth pain;
• infections or inflammation of the mouth, esophagus, stomach, and intestines, sometimes with accompanying pain or bleeding, poor intestinal motility (including intestinal obstruction), discomfort in the abdominal or esophageal area, difficulty swallowing;
• skin infections;
• bacterial and viral infections;
• tooth infection;
• pancreatitis, bile duct obstruction;
• genital pain, erectile dysfunction;
• weight gain;
• thirst;
• hepatitis;
• disorders related to the injection site or use of a venous catheter;
• skin reactions (which can be severe and life-threatening), skin ulcers;
• bruises, falls, and injuries;
• inflammation or bleeding of blood vessels in the form of small red or purple spots (usually on the legs) to large, bruise-like spots under the skin;
• mild cysts;
• severe reversible brain disorders, including seizures, high blood pressure, headaches, fatigue, confusion, blindness, or other vision disorders.

Rare Side Effects (May Affect Up to 1 in 1000 People):

• heart disease, including heart attack, angina;
• severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome);
• flushing attacks;
• vein discoloration;
• 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 eyes and skin);
• severe allergic reaction (anaphylactic shock) with symptoms such as difficulty breathing, chest pain, and/or dizziness/lightheadedness, severe itching of the skin or hives, 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, loss of body mass;
• increased appetite;
• fistula;
• joint effusion;
• ganglion cyst (a type of cyst that forms on the joint membrane);
• bone fractures;
• muscle fiber breakdown leading to further complications;
• liver swelling, liver bleeding;
• kidney cancer;
• skin changes similar to psoriasis;
• skin cancer;
• pale skin;
• increased platelet count or plasma cells (a type of white blood cell) in the blood;
• blood clotting in small blood vessels (microangiopathic thrombocytopenia);
• abnormal reaction to blood transfusion;
• partial or complete loss of vision;
• decreased libido;
• excessive salivation;
• exophthalmos (bulging eyes);
• photophobia;
• rapid breathing;
• rectal pain;
• gallstones;
• hernia;
• injuries;
• brittle or weak nails;
• abnormal protein deposition in organs;
• coma;
• intestinal ulcers;
• multi-organ failure;
• death.

If you are receiving Bortezomib Krka 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 hands or feet due to nerve damage;
• nausea or vomiting;
• diarrhea;
• mouth ulcers;
• constipation;
• muscle pain, bone pain;
• hair loss and abnormal hair structure;
• fatigue, feeling weak;
• fever.

Common Side Effects (May Affect Up to 1 in 10 People):

• shingles (localized around the eyes or widespread);
• herpes virus infection;
• bacterial and viral infections;
• respiratory tract infections, bronchitis, cough with sputum production, flu-like symptoms;
• fungal infections;
• allergic reactions;
• insulin deficiency or resistance to normal insulin levels;
• fluid retention;
• sleep disorders;
• loss of consciousness;
• disorders of consciousness, confusion;
• dizziness;
• rapid heartbeat, high blood pressure, sweating;
• abnormal vision, blurred vision;
• heart failure, heart attack, chest pain, feeling of discomfort in the chest, rapid or slow heart rate;
• high or low blood pressure;
• sudden drop in blood pressure when standing up, which may cause fainting;
• shortness of breath during exercise;
• cough;
• ringing or discomfort in the ears;
• gastrointestinal bleeding;
• heartburn;
• abdominal pain, bloating;
• difficulty swallowing;
• infection or inflammation of the stomach or intestines;
• abdominal pain;
• mouth or lip pain, throat pain;
• liver function changes;
• itching;
• redness;
• rash;
• muscle spasms;
• urinary tract infections;
• limb pain;
• swelling, including around the eyes and other parts of the body;
• chills;
• redness and pain at the injection site;
• general feeling of being unwell;
• weight loss;
• weight gain.

Uncommon Side Effects (May Affect Up to 1 in 100 People):

• hepatitis;
• severe allergic reaction (anaphylactic reaction), which can cause symptoms such as difficulty breathing, chest pain, and/or dizziness/lightheadedness, severe itching of the skin or hives, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse;
• movement disorders, paralysis, muscle twitching;
• dizziness;
• hearing loss, deafness;
• lung disorders making 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 eyes and skin);
• stye (hordeolum), redness and swelling of the eyelids.

Rare Side Effects (May Affect Up to 1 in 1000 People):

• blood clotting in small blood vessels (microangiopathic thrombocytopenia);
• severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome).

Reporting Side Effects

If you experience any side effects, tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in the "Contact" section below.

5. How to Store Bortezomib Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

Do not store above 30°C.

Store the vial in the outer carton in order to protect from light.

It has been shown that the reconstituted solution is chemically and physically stable for at least 8 hours at 25°C in the original vial.

From a microbiological point of view, unless the method of opening/constitution/dilution precludes the risk of microbial contamination, the diluted solution should be used immediately.

If not used immediately, the in-use storage times and conditions are the responsibility of the user.

The total storage time of the diluted solution should not exceed 8 hours.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Bortezomib Krka Contains

• The active substance is bortezomib. Each vial contains 1 mg of bortezomib (as a boron ester and mannitol).
• The other ingredients are mannitol and nitrogen.

What Bortezomib Krka Looks Like and Contents of the Pack

Bortezomib Krka powder for solution for injection is a white or off-white lyophilized powder or powder.

The 5 ml vial of colorless glass type I with a grey rubber stopper and green flip-off cap contains 1 mg of bortezomib.

Bortezomib Krka is available in packs containing 1 vial.

Marketing Authorization Holder and Manufacturer

Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For Further Information on This Medicinal Product, Please Contact the Local Representative of the Marketing Authorization Holder:

Krka-Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, tel. 22 57 37 500

This Medicinal Product is Authorized in the Member States of the EEA Under the Following Names:

DE:

Bortezomib Krka 1 mg Pulver zur Herstellung einer Injektionslösung, Bortezomib Krka 3,5 mg Pulver zur Herstellung einer Injektionslösung

SK:

CZ:

Bortezomib Krka

PL:

Bortezomib Krka

HU:

Bortezomib Krka 1 mg por oldatos injekcióhoz, Bortezomib Krka 3,5 mg por oldatos injekcióhoz

BG:

Бортезомиб Крка 1 mg прах за инжекционен разтвор, Бортезомиб Крка 3,5 mg прах за инжекционен разтвор

RO:

Bortezomib Krka 1 mg pulbere pentru soluţie injectabilă, Bortezomib Krka 3,5 mg pulbere pentru soluţie injectabilă

LT:

Bortezomib Krka 1 mg milteliai injekciniam tirpalui, Bortezomib Krka 3,5 mg milteliai injekciniam tirpalui

LV:

Bortezomib Krka 1 mg pulveris injekciju šķīduma pagatavošanai, Bortezomib Krka 3,5 mg pulveris injekciju šķīduma pagatavošanai

EE:

Bortezomib Krka

SI:

Bortezomib Krka 1 mg prašek za raztopino za injiciranje, Bortezomib Krka 3,5 mg prašek za raztopino za injiciranje

HR:

Bortezomib Krka 1 mg prašak za otopinu za injekciju, Bortezomib Krka 3,5 mg prašak za otopinu za injekciju

AT:

Bortezomib HCS 1 mg Pulver zur Herstellung einer Injektionslösung, Bortezomib HCS 3,5 mg Pulver zur Herstellung einer Injektionslösung

BE:

Bortezomib Krka 1 mg poeder voor oplossing voor injectie, Bortezomib Krka 3,5 mg poeder voor oplossing voor injectie

DK:

Bortezomib Krka

Date of Last Revision of the Leaflet:29.04.2021

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Information for Healthcare Professionals Only:

Bortezomib Krka, 1 mg, Powder for Solution for Injection

1. Preparation of the Solution for Injection

Caution: Bortezomib Krka is a cytotoxic medicine. When handling the medicine and preparing it for use, caution should be exercised. To protect the skin from contact with the medicine, gloves and other protective clothing are recommended.

• 1.1 Reconstitution of the 1 mg Vial: Add 1 ml of sterile 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the powder. Use a 1 ml syringe and do not remove the stopper. The 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 should 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 any are observed, discard the solution. Check the concentration on the vial to ensure the correct dose is administered intravenously(1 mg/ml).
• 1.3 The reconstituted solution does not contain preservatives and should be used immediately after reconstitution. However, the chemical and physical stability of the reconstituted solution has been demonstrated for 8 hours at 25°C in the original vial and/or syringe. The total storage time of the reconstituted solution should not exceed 8 hours. If the reconstituted solution is not used immediately, the storage conditions and times are the responsibility of the user. There is no need to protect the reconstituted solution from light.

2. Administration

• Draw the appropriate dose of the reconstituted solution into a syringe, 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 as for intravenous use).
• Administer the solution as an intravenous bolus over 3 to 5 seconds.
• Flush the intravenous line with a small amount of sterile 9 mg/ml (0.9%) sodium chloride solution for injection.

Bortezomib Krka (1 mg Powder for Solution for Injection)

IS FOR INTRAVENOUS USE ONLY. DO NOT ADMINISTER BY ANY OTHER ROUTE. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.

3. Disposal of the Medicine

The vial is for single use only, and any unused solution should be discarded.

Dispose of any unused medicine or waste material in accordance with local requirements.