Bortezomib Reddi

Leaflet accompanying the packaging: information for the user

Bortezomib Reddy, 3.5 mg, powder for solution for injection

bortezomib

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any doubts.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bortezomib Reddy and what is it used for
• 2. Important information before using Bortezomib Reddy
• 3. How to use Bortezomib Reddy
• 4. Possible side effects
• 5. How to store Bortezomib Reddy
• 6. Package contents and other information

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

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

• 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 in whom hematopoietic stem cell transplantation has failed or is 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 Reddy is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients aged 18 and over in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, in whom the disease has not been previously treated and who do not qualify for hematopoietic stem cell transplantation.

2. Important information before using Bortezomib Reddy

When not to use Bortezomib Reddy

• 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 certain severe lung or heart diseases.

Warnings and precautions

The patient should inform their doctor if they:

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

The patient must have regular blood tests before and during treatment with bortezomib to regularly check the blood cell count.
If the patient has mantle cell lymphoma and is receiving bortezomib with a rituximab-containing regimen, they should tell their doctor:

• if they suspect or have had hepatitis B virus infection in the past. In a few cases, patients who had hepatitis B infection may have had recurring episodes of hepatitis, which could be fatal. If the patient has a history of hepatitis B, they will be closely monitored by their doctor for signs of active hepatitis B.

Before starting treatment with bortezomib, the patient should carefully read the leaflets of all medicinal products they are taking during treatment to obtain information about them. When taking thalidomide, pregnancy must be ruled out, and effective contraception must be used (see "Pregnancy and breastfeeding").

Children and adolescents

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

Bortezomib Reddy and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking medicines containing 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, used to treat epilepsy;
• St. John's wort (Hypericum perforatum), used to treat depression and other conditions;
• oral antidiabetic drugs.

Pregnancy and breastfeeding

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

Driving and using machines

Bortezomib may cause fatigue, dizziness, fainting, and blurred vision. If these symptoms occur, the patient should not drive or operate tools or machines; even if the symptoms do not occur, the patient should still be cautious.

3. How to use Bortezomib Reddy

The doctor will adjust the appropriate dose of bortezomib for the patient based on the patient's height and weight (body surface area). The most commonly used initial dose of bortezomib is 1.3 mg/m2 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).
Progressive multiple myeloma
If bortezomib is administered as a single drug, the patient will receive 4 doses of bortezomib 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 in combination with pegylated liposomal doxorubicin or dexamethasone.
When bortezomib is administered with pegylated liposomal doxorubicin, the patient will receive bortezomib 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 after bortezomib injection on day 4 of the 21-day bortezomib treatment cycle.
The patient may receive up to 8 cycles (24 weeks).
When bortezomib is administered with dexamethasone, the patient will receive bortezomib 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 21-day bortezomib treatment 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 patient does notqualify for hematopoietic stem cell transplantation, they will receive bortezomib 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 is administered twice a week, on days 1, 4, 8, 11, 22, 25,
• 29, and 32.
• During cycles 5-9, bortezomib 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.
If the patient has not been previously treated for multiple myeloma and the patientqualifies for hematopoietic stem cell transplantation, they will receive bortezomib intravenously or subcutaneously in combination with dexamethasone or dexamethasone with thalidomide for induction treatment.
When bortezomib is administered with dexamethasone, the patient will receive bortezomib intravenously or subcutaneously 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 in the 21-day bortezomib treatment cycle.
The patient will receive up to 4 cycles (12 weeks).
When bortezomib 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 in the 28-day bortezomib treatment cycle, and thalidomide will be administered orally once a day at a dose of 50 mg until day 14 of the first cycle, and if the dose is tolerated, it will be increased to 100 mg on days 15-28 and may be further increased to 200 mg per day from the second cycle. The patient may receive up to 6 cycles (24 weeks).

• The patient may receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma
If the patient has not been previously treated for mantle cell lymphoma, they will receive bortezomib intravenously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.
Bortezomib 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).
The following drugs are administered as intravenous infusions on day 1 of each 21-day bortezomib 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 administered orally at a dose of 100 mg/m2 on days 1, 2, 3, 4, and 5 of the bortezomib treatment cycle.

How Bortezomib Reddy is administered

This medicine is administered intravenously or subcutaneously. Bortezomib will be administered by medical personnel with experience in the use of cytotoxic drugs.
The bortezomib powder must be dissolved before administration. The preparation of the medicine is carried out by medical personnel. 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.

Overdose of Bortezomib Reddy

Since this medicine is administered by a doctor or nurse, it is unlikely that the patient will receive too much of the medicine.
If this happens, the doctor will monitor the patient 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 the patient is receiving bortezomib for multiple myeloma or mantle cell lymphoma, they should immediately tell their doctor if they experience any of the following symptoms:

• muscle cramps, muscle weakness;
• disorientation, 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 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 to regularly check the blood cell count.
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, or brain hemorrhage);
• 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 the patient is receiving bortezomib for multiple myeloma, they may experience the following side effects:

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

• hypersensitivity, numbness, tingling, or burning sensation of the skin, pain in the hands or feet due to nerve damage;
• decrease in red and (or) white blood cells (see above);
• fever;
• nausea or vomiting, loss of appetite;
• constipation occurring with or without bloating (symptom severity may be significant);
• diarrhea: if this happens, the patient should drink more water than usual, and the doctor may recommend taking additional medicines to control diarrhea;
• 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 when standing up, which can lead to fainting;
• high blood pressure;
• decreased kidney function;
• headache;
• general feeling of being unwell, pain, dizziness, drowsiness, 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 nodules 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 inflammation, dry mouth, mouth ulcers or throat pain;
• weight loss, loss of taste;
• muscle cramps, muscle weakness, bone pain;
• blurred vision;
• conjunctivitis;
• nosebleeds;
• difficulty sleeping, sweating, anxiety, mood swings, depressive mood, restlessness or agitation, changes in mental state, disorientation;
• 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, 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 damage;
• paralysis, seizures, falls, movement disorders, abnormal or changed sensation (touch, hearing, taste, smell), attention disorders, tremors, twitching;
• joint inflammation, including joint inflammation of 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;
• hiccups;
• speech disorders;
• increased or decreased urine production (due to kidney damage), painful urination, or blood/protein in the urine, fluid retention;
• altered level of consciousness, disorientation, worsening or loss of memory;
• hypersensitivity;
• 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), eyelid redness and swelling, eye discharge, vision disorders, eye bleeding;
• 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;
• infection or inflammation of the mouth, esophagus, stomach, and intestines, sometimes with accompanying pain and bleeding, poor intestinal motility (including obstruction), abdominal discomfort and esophagus, difficulty swallowing, vomiting blood;
• skin infection;
• bacterial and viral infections;
• tooth infection;
• pancreatitis, bile duct obstruction;
• genital pain, erectile dysfunction disorders;
• weight gain;
• thirst;
• hepatitis;
• disorders at the injection site or related to the use of a vascular catheter;
• skin reactions and disorders (which can be severe and life-threatening), skin ulcers;
• bruises, falls, and injuries;
• inflammation or bleeding of blood vessels, manifested by small red or purple spots (usually on the legs) to large, bruise-like spots under the skin;
• mild cysts;
• severe reversible disorders of the brain, which include seizures, high blood pressure, headache, fatigue, disorientation, blindness, or other vision disorders.

Rare side effects (may affect up to 1 in 1000 people):

• heart disease, including heart attack, angina pectoris;
• flushing;
• vein discoloration;
• spinal cord inflammation;
• ear disorders, ear bleeding;
• hypothyroidism;
• Budd-Chiari syndrome (clinical symptoms caused by blockage of hepatic veins);
• abnormal or changed intestinal function;
• brain bleeding;
• jaundice (yellowing of the skin and eyes);
• stye (hordeolum), eyelid redness and swelling, eye discharge, vision disorders, eye bleeding;

If the patient is receiving bortezomib with other medicines for mantle cell lymphoma, they may experience the following side effects:

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

• pneumonia;
• loss of appetite;
• hypersensitivity, numbness, tingling, or burning sensation of the skin, pain in the 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 of weakness;
• fever.

Common side effects (may affect up to 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;
• hypersensitivity (allergic reaction);
• insulin deficiency or resistance to normal insulin levels;
• fluid retention;
• sleep disorders;
• loss of consciousness;
• altered level of consciousness, confusion;
• dizziness;
• rapid heartbeat, high blood pressure, sweating;
• abnormal or changed 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 standing up, which can lead to fainting;
• shortness of breath during exercise;
• cough;
• hiccups;
• ringing or discomfort in the ears;
• gastrointestinal bleeding;
• heartburn;
• abdominal pain, belching;
• difficulty swallowing;
• infection or inflammation of the stomach or intestines;
• abdominal pain;
• mouth or lip inflammation, throat pain;
• liver function changes;
• itching;
• skin redness;
• rash;
• muscle cramps;
• 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 illness;
• 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 or tightness, dizziness or fainting, severe itching of the skin or hives, facial swelling, lip, tongue, or throat swelling, which can cause difficulty swallowing, and collapse;
• movement disorders, paralysis, tremors;
• 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;
• blood clots in the lungs;
• jaundice (yellowing of the skin and eyes);
• stye (hordeolum), eyelid redness and swelling.

Rare side effects (may affect up to 1 in 1000 people):

• blood clot in small blood vessels (thrombotic microangiopathy),
• severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bortezomib Reddy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and outer packaging, after "Expiry date (EXP)". The expiry date refers to the last day of that month.
Do not store above 25°C. Store the vial in the outer packaging to protect from light.
After reconstitution
Chemical and physical stability for up to 8 hours at 25°C and up to 15 days at 2-8°C in the original vial and/or polypropylene syringe has been demonstrated. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and are normally not more than 24 hours at 2-8°C, unless reconstitution has been carried out in controlled and validated aseptic conditions.
Bortezomib Reddy is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

6. Package contents and other information

What Bortezomib Reddy contains

• The active substance of the medicine is bortezomib. Each vial contains 3.5 mg of bortezomib (as boron acid ester with mannitol).
• The other ingredient (excipient) is mannitol.

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

What Bortezomib Reddy looks like and contents of the pack

Bortezomib Reddy powder for solution for injection is a white or off-white lyophilized powder or powder.
Each pack of Bortezomib Reddy 3.5 mg - powder for solution for injection contains a glass vial (type I) with a stopper and flip-off cap.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany

Manufacturer/Importer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
RUAL LABORATORIES S.R.L.
Splaiul Unirii nr.313, Building H, 1st floor, sector 3,
030138 Bucharest
Romania

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

Germany:
Bortezomib beta 3.5 mg Pulver zur Herstellung einer Injektionslösung
Belgium:
Bortezomib Reddy 3.5 mg poeder voor oplossing voor injectie
Denmark:
Bortezomib Reddy
Finland:
Bortezomib Reddy 3.5 mg injektiokuiva-aine, liuosta varten
Hungary:
Bortezomib Reddy 3.5 mg por oldatos injekcióhoz
Ireland:
Bortezomib 3.5 mg powder for solution for injection
Netherlands:
Bortezomib Reddy 3.5 mg poeder voor oplossing voor injectie
Norway:
Bortezomib Reddy
Austria:
Bortezomib Reddy 3.5 mg Pulver zur Herstellung einer Injektionslösung
Poland:
Bortezomib Reddy
Portugal:
Bortezomib Reddy 3.5 mg pó para solução injetável
Slovakia:
Bortezomib Reddy 3.5 mg prášok na injekčný roztok
Sweden:
Bortezomib Reddy 3.5 mg pulver till injektionsvätska, lösning
Czech Republic:
Bortezomib Reddy

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

1. PREPARATION OF INTRAVENOUS INJECTION SOLUTION

Caution: Bortezomib is a cytotoxic product. When handling the medicine and preparing it for use, caution should be exercised. To protect against skin contact with the medicine, the use of gloves and other protective clothing is recommended.
Pregnant women should not handle this medicinal product.
AS BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED WHEN HANDLING THE MEDICINE.

• 1.1. Preparation of the 3.5 mg vial: carefully add 3.5 mlof sterile, 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing bortezomib powder, using an appropriate syringe, without removing the vial stopper. Dissolution of the lyophilized powder takes less than 2 minutes.

The concentration of the resulting solution will be 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, the solution should be visually inspected for particulate matter and discoloration. If particulate matter or discoloration is observed, the solution should be discarded. Ensure that the correct dose is administered intravenously(1 mg/ml).
• 1.3. Chemical and physical stability for up to 8 hours at 25°C and up to 15 days at 2-8°C in the original vial and/or polypropylene syringe has been demonstrated. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and are normally not more than 24 hours at 2-8°C, unless reconstitution has been carried out in controlled and validated aseptic conditions.

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

2. ADMINISTRATION

• After reconstitution, the appropriate volume of the prepared solution should be withdrawn according to the dose calculated based on the patient's body surface area.
• Before administration, the dose and concentration of the medicine in the syringe should be confirmed (check if the syringe is labeled for intravenous administration).
• The solution should be administered as an intravenous injection (bolus) over 3 to 5 seconds through a centrally or peripherally inserted intravenous catheter.
• The intravenous catheter through which the medicine was administered should be flushed with a small amount of sterile 9 mg/ml (0.9%) sodium chloride injection solution.

Bortezomib Reddy powder for solution for injection 3.5 mg

ADMINISTERED INTRAVENOUSLY OR SUBCUTANEOUSLY. DO NOT ADMINISTER BY OTHER ROUTES. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.

3. DISPOSAL OF THE MEDICINE

The vial is for single use only, and any remaining solution should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements
Information intended for healthcare professionals only:
Only the 3.5 mg vial can be used for subcutaneous administration, as described below.

1. PREPARATION OF SUBCUTANEOUS INJECTION SOLUTION

Caution: Bortezomib is a cytotoxic product. When handling the medicine and preparing it for use, caution should be exercised. To protect against skin contact with the medicine, the use of gloves and other protective clothing is recommended.
Pregnant women should not handle this medicinal product.
AS BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED WHEN HANDLING THE MEDICINE.

• 1.1. Preparation of the 3.5 mg vial: carefully add 1.4 mlof sterile, 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing bortezomib powder, using an appropriate syringe, without removing the vial stopper. Dissolution of the lyophilized powder takes less than 2 minutes.

The concentration of the resulting solution will be 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, the solution should be visually inspected 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. Chemical and physical stability for up to 8 hours at 25°C and up to 15 days at 2-8°C in the original vial and/or polypropylene syringe has been demonstrated. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and are normally not more than 24 hours at 2-8°C, unless reconstitution has been carried out in controlled and validated aseptic conditions.

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

2. ADMINISTRATION

• After reconstitution, the appropriate volume of the prepared solution should be withdrawn according to the dose calculated based on the patient's body surface area.
• Before administration, the dose and concentration of the medicine in the syringe should be confirmed (check if the syringe is labeled for subcutaneous administration).
• The solution should be administered subcutaneously at an angle of 45-90°.
• The prepared solution is administered subcutaneously into the thigh (right or left) or abdomen (right or left side).
• The injection site should be changed for each subsequent injection.
• If a local reaction occurs after subcutaneous injection of bortezomib, it is recommended to administer the subcutaneous injection of bortezomib at a lower concentration (dilution to 1 mg/ml instead of 2.5 mg/ml) or to switch to intravenous administration.

Bortezomib Reddy powder for solution for injection 3.5 mg

ADMINISTERED INTRAVENOUSLY OR SUBCUTANEOUSLY. DO NOT ADMINISTER BY OTHER ROUTES. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.

3. DISPOSAL OF THE MEDICINE

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