BORTEZOMIB VIATRIS 3.5 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Bortezomib Viatris 3.5mg powder for solution for injection EFG

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

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

Contents of the pack:

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

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

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

Bortezomib Viatris is used to treat multiple myeloma (a cancer of the bone marrow) in patients aged 18 and over:

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

Bortezomib Viatris 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 the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients who have not received previous treatment and for those patients who are not considered suitable for a blood stem cell transplant.

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

Do not use Bortezomib Viatris

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Bortezomib Viatris if you experience any of the following:

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

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

You must inform your doctor if you have mantle cell lymphoma and are given rituximab in combination with Bortezomib Viatris:

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

Children and adolescents

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

Other medicines and Bortezomib Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are using medicines that contain 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 for depression or other conditions
• oral antidiabetics

Pregnancy and breastfeeding

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

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

Do not breastfeed while using bortezomib. Consult your doctor when it is safe to restart breastfeeding after finishing your treatment.

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

Driving and using machines

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

3. How to use Bortezomib Viatris

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

Progressive multiple myeloma

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

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

When bortezomib is given with liposomal doxorubicin, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle and liposomal doxorubicin 30 mg/m² will be administered on day 4 of the 21-day bortezomib treatment cycle, by intravenous infusion after bortezomib injection.

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

When bortezomib is given with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle and dexamethasone will be administered orally in doses of 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the 21-day bortezomib treatment cycle.

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

Previously untreated multiple myeloma

If you have not been treated before for multiple myeloma and are not a candidatefor a blood stem cell transplant, you will receive bortezomib with the other two medicines; melphalan and prednisone.

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

• In cycles 1 to 4, Bortezomib Viatris is administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, Bortezomib Viatris is administered once a week on days 1, 8, 22, and 29.

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

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

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

You will receive 4 cycles (12 weeks).

When bortezomib is given with thalidomide and dexamethasone, the duration of a treatment cycle is 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 bortezomib treatment cycle, and thalidomide will be administered orally once daily at a dose of 50 mg until day 14 of the first cycle, and if tolerated, the thalidomide dose will be increased to 100 mg on days 15-28, and from the second cycle onwards, it may be increased further to 200 mg daily.

You may receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

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

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

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

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

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

How Bortezomib Viatris is administered

This medicine must be used by intravenous or subcutaneous injection. It will be administered to you by a healthcare professional who is experienced in the use of cytotoxic medicines.

The bortezomib powder must be dissolved before administration. This will be done by a healthcare professional. Then, the reconstituted solution will be injected into a vein or by subcutaneous injection. The injection into a vein only takes 3 to 5 seconds. The subcutaneous injection is given in the thighs or abdomen.

If you receive more Bortezomib Viatris than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible Adverse Effects

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

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

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

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

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

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

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

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

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

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

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

• Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate
• Kidney failure
• Inflammation of a vein, blood clots in the veins and lungs
• Blood coagulation problems
• Insufficient circulation
• Inflammation of the heart lining or fluid around the heart
• Infections, including urinary tract infections, flu, herpes virus infection, ear infection, and cellulitis
• Bloody stools or bleeding in the mucous membranes, for example, in the mouth or vagina
• Cerebrovascular disorders
• Paralysis, convulsions, falls, movement disorders, alterations or changes in, or decreased sensitivity (touch, hearing, taste, smell), attention disorders, tremors, shaking
• Arthritis, including inflammation of the joints of the hands and feet and jaw
• Disorders that affect the lungs, preventing the body from receiving enough oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that can become shallow, difficult, or stop, panting breathing
• Hiccup, speech disorders
• Increased or decreased urine production (due to kidney damage), pain when urinating, or blood/proteins in the urine, fluid retention
• Alteration of the level of consciousness, confusion, alteration or loss of memory
• Hypersensitivity
• Hearing loss, deafness, or ringing in the ears, ear discomfort
• Hormonal alterations that can affect salt and water absorption
• Hyperactivity of the thyroid gland
• Inability to produce enough insulin or resistance to normal insulin levels
• Eye irritation or inflammation, watery eyes, eye pain, dry eyes, eye infections, eyelid cyst (chalazion), reddened and swollen eyelids, tearing (lacrimation), abnormal vision, eye bleeding
• Swelling of lymph nodes
• Stiffness of the joints or muscles, feeling of heaviness, pain in the groin
• Hair loss and abnormal hair texture
• Allergic reactions
• Redness or pain at the injection site
• Mouth pain
• Mouth or esophagus, stomach, and intestine infections, sometimes associated with pain or bleeding, intestinal movement (including obstruction), abdominal or esophageal discomfort, difficulty swallowing, vomiting blood
• Skin infections
• Bacterial and viral infections
• Dental infections
• Pancreatitis, bile duct obstruction
• Genital pain, problems achieving an erection
• Weight gain
• Thirst
• Hepatitis
• Disorders at the injection site or related to the injection device
• Skin reactions and disorders (which can be severe and life-threatening), skin ulcers
• Bruises, falls, and injuries
• Inflammation or bleeding of blood vessels that can appear as small red or purple spots (usually on the legs) to large patches similar to bruises under the skin or tissue.
• Benign cysts
• A severe and reversible disorder in the brain that includes convulsions, high blood pressure, headaches, fatigue, confusion, blindness, or other vision problems.

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

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

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

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

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

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

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

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

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

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

• Blood clot in small blood vessels (thrombotic microangiopathy)

Reporting of Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Bortezomib Viatris

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

Do not use this medicine after the expiration date that appears on the vial and on the packaging after CAD.

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

This medicine does not require special temperature storage conditions.

Reconstituted Solution

The chemical and physical stability during use has been demonstrated for 8 days at 25°C and for 15 days at 5 ± 3°C in the dark, both in a vial and in a polypropylene syringe.

From a microbiological point of view, unless the method of reconstitution or dilution excludes the risk of bacterial contamination, the medicine must be used immediately. Otherwise, the storage time and conditions of use are the responsibility of the user.

This medicine is for single use only.

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

6. Package Contents and Additional Information

Composition of Bortezomib Viatris

• The active ingredient is bortezomib. Each vial contains 3.5 mg of bortezomib (as boric ester of mannitol).
• The other component is mannitol (E421).

Reconstitution for intravenous administration:

After reconstitution, 1 ml of the solution for intravenous injection contains 1 milligram of bortezomib.

Reconstitution for subcutaneous administration:

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

Appearance of Bortezomib Viatris and Package Contents

White or off-white powder or paste.

Bortezomib Viatris is packaged in a glass vial with a rubber stopper and a green flip-off cap.

Each box contains a single-use vial.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Synthon Hispania S.L.

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon s.r.o.

Brnenská 32 /cp. 597

678 01 Blansko

Czech Republic

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Date of the last revision of this leaflet: March 2021

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

This information is intended only for healthcare professionals:

1.

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

SINCE BORTEZOMIB VIATRIS LACKS PRESERVATIVES, STRICT ASEPTIC TECHNIQUE SHOULD BE FOLLOWED DURING ITS HANDLING.

1.1Preparation of a 3.5mg vial: carefully add 3.5mlof sterile sodium chloride 9 mg/ml (0.9%) injection solution to the vial containing Bortezomib Viatris powder using a suitably sized syringe without removing the vial cap. The dissolution of the lyophilized powder is completed in less than 2 minutes.

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

1.2Before administration, visually inspect the solution to rule out the presence of particles and color alteration. If any color alteration or particle is observed, the solution should be discarded. Ensure that the correct dose is being used for intravenous administration (1 mg/ml).

1.3 The reconstituted solution lacks preservatives and should be used immediately after preparation. However, chemical and physical stability during use has been demonstrated for 8 days at 25°C and for 15 days at 5 ± 3°C in the dark, stored in the original vial or in a syringe. From a microbiological point of view, unless the reconstitution or dilution method excludes the risk of bacterial contamination, the drug should be used immediately. Otherwise, the storage time and conditions of use are the responsibility of the user.

2.

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

BORTEZOMIB VIATRIS 3.5mg powder for injectable solution SHOULD BE ADMINISTERED ONLY BY SUBCUTANEOUS OR INTRAVENOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused death.

3.

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

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

This information is intended only for healthcare professionals:

Only the 3.5 mg vial can be administered subcutaneously, as described below:

1.

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

SINCE BORTEZOMIB VIATRIS LACKS PRESERVATIVES, STRICT ASEPTIC TECHNIQUE SHOULD BE FOLLOWED DURING ITS HANDLING.

1.1Preparation of a 3.5mg vial: carefully add 1.4mlof sterile sodium chloride 9 mg/ml (0.9%) injection solution to the vial containing Bortezomib Viatris powder using a suitably sized syringe without removing the vial cap. The dissolution of the lyophilized powder is completed in less than 2 minutes.

The concentration of the resulting solution will be 2.5 mg/ml. The solution should be colorless and transparent, with a final pH of 4 to 7. It is not necessary to check the pH of the solution.

1.2 Before administration, visually inspect the solution to rule out the presence of particles and color alteration. If any color alteration or particle is observed, the solution should be discarded. Ensure that the correct dose is being used for subcutaneous administration (2.5 mg/ml).

1.3 The reconstituted medication lacks preservatives and should be used immediately after preparation. However, chemical and physical stability during use has been demonstrated for 8 days at 25°C and for 15 days at 5 ± 3°C in the dark, stored in the original vial or in a syringe. From a microbiological point of view, unless the reconstitution or dilution method excludes the risk of bacterial contamination, the drug should be used immediately. Otherwise, the storage time and conditions of use are the responsibility of the user.

2.

• Once dissolved, withdraw the appropriate amount of the reconstituted solution based on the calculated dose based on the patient's Body Surface Area.
• Confirm the dose and concentration contained in the syringe before use. (Check that the syringe is marked for subcutaneous administration.)
• Inject the solution subcutaneously at an angle of 45-90°.
• The reconstituted solution is administered subcutaneously in the thighs (right or left) or abdomen (right or left side).
• The injection site should be rotated for successive injections.
• If local reactions occur at the injection site after subcutaneous injection of this medication, a less concentrated bortezomib solution (1 mg/ml instead of 2.5 mg/ml) can be administered subcutaneously or it is recommended to switch to intravenous injection.

BORTEZOMIB VIATRIS 3.5mg powder for injectable solution SHOULD BE ADMINISTERED BY SUBCUTANEOUS OR INTRAVENOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused death.

3.

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

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.