Prospecto: Information for the User

?ortezomib Viatris 3.5mg Powder for Injection EFG

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, andyou may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section4.

1.?ortezomib Viatris Description and Indications

2.Important Information Before Using ?ortezomib Viatris

3.How to Use ?ortezomib Viatris

4.Adverse Effects

5.Storage of ?ortezomib Viatris

6.Contents of the Package and Additional Information

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

Viatris bortezomib is used in the treatment of multiple myeloma (a bone marrow cancer) in patients aged 18 years or older:

• alone or in combination with pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (in progression) after receiving at least one previous treatment and for those patients whose stem cell transplant did not work or is not suitable.
• in combination with melphalan and prednisone, for patients whose disease has not been previously treated and who are not suitable to receive high doses of chemotherapy prior to a stem cell transplant.
• in combination with dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and who receive high doses of chemotherapy prior to a stem cell transplant (induction treatment).

Viatris bortezomib is used in the treatment of mantle cell lymphoma (a type of cancer that affects lymph nodes) in patients aged 18 years or older in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients whose disease has not been previously treated and for those patients who are not considered suitable for a stem cell transplant.

Do not use Viatris bortezomib

• if you are allergic to bortezomib, boron, or any of the other ingredients in this medication (listed in section6)
• if you have severe lung or heart problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Viatris bortezomib if you experience the following:

• low red or white blood cell count
• bleeding problems and/or low platelet count in blood
• diarrhea, constipation, nausea, or vomiting
• history of fainting, dizziness, or drowsiness
• kidney problems
• mild 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 (including around the eyes or spread over the body)
• symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss or changes in vision, and difficulty breathing
• memory loss, changes in thought, difficulty walking, or loss of vision. These may be signs of a severe brain infection, and your doctor may advise further testing and follow-up.

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

Inform your doctor if you have multiple myeloma and are receiving rituximab with Viatris bortezomib:

• if you think you currently have or have had hepatitis in the past. In a few cases, patients who have had hepatitis B may have repeated attacks of hepatitis, which can be fatal. If you have a history of hepatitis B, you will be closely monitored by your doctor to detect signs of active hepatitis B.

Before starting treatment with bortezomib, read the leaflets of all medications you are taking in combination with bortezomib to consult the information related to these medications. 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 medication should not be used in children and adolescents because it is not known how the medication will affect them.

Other medications and Viatris bortezomib

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Particularly, inform your doctor if you are using medications that contain any of the following active ingredients:

• ketoconazole, used to treat fungal infections
• ritonavir, to treat HIV infection
• rifampicin, an antibiotic to treat bacterial infections
• carbamazepine, phenytoin, or phenobarbital used to treat epilepsy
• St. John's Wort (Hypericum perforatum), used for depression or other situations,
• oral antidiabetic medications

Pregnancy and breastfeeding

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

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

You should not breastfeed while using bortezomib. Consult your doctor when it is safe to resume breastfeeding after completing your treatment.

Bortezomib, when used in combination with thalidomide, causes birth defects and fetal death. When bortezomib is administered with thalidomide, follow the thalidomide pregnancy prevention program (consult the thalidomide leaflet).

Driving and operating machinery

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

Your doctor will tell you the dose of the medication 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 modify the dose and the total number of treatment cycles based on your response to treatment, the appearance of certain side effects, and your underlying condition (e.g., liver problems).

Progressive multiple myeloma

When bortezomib is administered alone, you will receive 4 doses of bortezomib via 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 along with the medications pegylated liposomal doxorubicin or dexamethasone.

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

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

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

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

Untreated multiple myeloma

If you have not been treated for multiple myeloma before and are not a candidate to receive a blood stem cell transplant, you will receive bortezomib along with two other medications; 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 the first week of each cycle.

If you have not received any previous treatment for multiple myeloma and are a candidate to receive a blood stem cell transplant, you will receive bortezomib via intravenous or subcutaneous injection along with dexamethasone, or dexamethasone and thalidomide, as induction treatment.

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

You will receive 4 cycles (12 weeks).

When bortezomib is administered with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).

Dexamethasone is administered orally in doses of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the bortezomib 28-day treatment cycle, and thalidomide is administered orally once a day in doses of 50 mg until day 14 of the first cycle, and if tolerated, the thalidomide dose is increased to 100 mg on days 15-28, and from the second cycle and onwards, it can be increased further to 200 mg daily.

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

Untreated mantle cell lymphoma

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

Bortezomib is administered via 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 medications are administered via intravenous infusion on day 1 of the bortezomib 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 is administered orally in doses of 100 mg/m² on days 1, 2, 3, 4, and 5 of the bortezomib treatment cycle.

How to administer bortezomib Viatris

This medication must be used via intravenous or subcutaneous injection. It will be administered by a healthcare professional experienced in the use of cytotoxic medications.

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

If you receive more bortezomib Viatris than you should

This medication will be administered by your doctor or nurse, so it is unlikely that you will receive an excessive amount. In the unlikely event of an overdose, your doctor will monitor you for any adverse effects.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of these side effects can be serious.

If you are given bortezomib for multiple myeloma or mantle cell lymphoma, tell your doctor right away if you notice any of the following symptoms:

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

Treatment with bortezomib can cause a very frequent decrease in the number of red and white blood cells and platelets in the blood. Therefore, you will have to make 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 the appearance of bruises (bruises), or bleeding without evident injury (for example, intestinal, stomach, mouth and gum bleeding or 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 the flu

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

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

• Sensitivity, numbness, tingling or burning sensation in the skin or pain in the hands or feet due to nerve damage
• Decrease in the number of red and white blood cells (see above)
• Fever
• Feeling unwell (nausea) or vomiting, loss of appetite
• Constipation with or without swelling (can be severe)
• Diarhea: 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 weak
• Muscle pain, bone pain

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

• Low blood pressure, sudden drop in blood pressure when standing, which could lead to fainting
• High blood pressure
• Decreased kidney function
• Headache
• General feeling of being unwell, pain, dizziness, feeling weak or loss of consciousness
• Chills
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, cough with mucus, flu-like illness
• Herpes zoster (localized including around the eyes or extended over the body)
• Chest pain or difficulty breathing while exercising
• Different types of rashes
• Itching skin, skin lumps or dry skin
• Facial flushing or small blood vessel rupture
• Redness of the skin
• Dehydration
• Heartburn, swelling, belching, flatulence, stomach pain, intestinal or stomach bleeding
• Alteration of liver function
• Mouth or lip sores, dry mouth, mouth ulcers or throat pain
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle weakness, pain in the limbs
• Blurred vision
• Conjunctivitis (infection of the outer layer of the eye and the inner surface of the eyelids)
• Nasal hemorrhages
• 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 side effects(can affect up to 1 in 100people)

• Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate
• Kidney failure
• Vein inflammation, blood clots in veins and lungs
• Blood clotting problems
• Poor circulation
• Pericarditis (inflammation of the heart lining) or fluid around the heart
• Infections, including urinary tract infections, flu, herpes virus infection, ear infection, and cellulitis
• Bleeding from mucous membranes, for example, from the mouth or vagina
• Cerebrovascular disorders
• Paralysis, seizures, falls, movement disorders, changes or decrease in sensitivity (touch, hearing, taste, smell), attention disorders, tremors, shakiness
• Arthritis, including inflammation of the joints of the fingers of the hands and feet and jaw
• Lung disorders, preventing the body from receiving a sufficient amount of oxygen. Some of them are difficulty breathing, shortness of breath, shortness of breath without exercise, shallow, difficult or stopping breathing, rapid breathing
• Hypophonia, speech disorders
• Decreased or increased urine production (due to kidney damage), pain while urinating or blood/protein in the urine, fluid retention
• Alteration of level of consciousness, confusion, alteration or loss of memory
• Hypersensitivity
• Loss of hearing, deafness or ringing in the ears, ear discomfort
• Alterations in hormone levels that can affect salt and water absorption
• Hyperthyroidism
• Inability to produce sufficient insulin or resistance to normal insulin levels
• Irritation or inflammation of the eyes, too moist eyes, eye pain, dry eyes, eye infections, chalazion (cyst on the eyelid), red and swollen eyelids, watery eyes (lacrimation), abnormal vision, eye hemorrhage
• Swelling of lymph nodes
• Joint or muscle stiffness, feeling of heaviness, pain in the groin
• Loss of hair and abnormal hair texture
• Allergic reactions
• Redness or pain at the injection site
• Mouth pain
• Mouth, lip, or throat infections, mouth ulcers, esophageal, stomach, or intestinal ulcers, associated with pain or bleeding, slow intestinal movement (including obstruction), abdominal or esophageal discomfort, difficulty swallowing, vomiting blood
• Skin infections
• Bacterial and viral infections
• Dental infection
• Pancreatitis, bile duct obstruction
• Genital pain, erectile dysfunction
• Weight gain
• Thirst
• Hepatitis
• Disorders at the injection site or related to the injection device
• Allergic reactions and skin disorders (which can be severe and life-threatening), skin ulcers
• Bruises, falls, and injuries
• Small blood vessel inflammation or bleeding under the skin or tissue.
• Benign cysts
• A severe and reversible brain disorder that includes seizures, high blood pressure, headaches, fatigue, confusion, blindness or other vision problems.

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

• Heart problems, including heart attack, angina
• Flushing
• Vein discoloration
• Spinal nerve inflammation
• Ear problems, ear hemorrhage
• Decreased thyroid function
• Syndrome of Budd-Chiari (clinical symptoms caused by obstruction of the hepatic veins)
• Changes or abnormalities in intestinal function
• Brain hemorrhage
• Yellow discoloration of the eyes and skin (jaundice)
• Severe allergic reaction (anaphylactic shock), whose signs can be difficulty breathing, chest pain or tightness and/or dizziness/fainting, intense itching skin or skin lumps, facial swelling, lips, tongue, and/or throat swelling, which can cause difficulty swallowing, collapse
• Breast disorders
• Vaginal rupture
• Genital inflammation
• Inability to tolerate alcohol consumption
• Emaciation or loss of body mass
• Increased appetite
• Fistula
• Joint effusion
• Benign cysts in the joint lining (synovial cysts)
• Fracture
• Disintegration of muscle fibers that causes other complications
• Swelling of the liver, liver hemorrhage
• Kidney cancer
• Skin condition 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 (microangiopathy)
• Abnormal reaction to blood transfusions
• Partial or total loss of vision
• Loss of libido
• Edema
• Severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome)
• Bulging eyes
• Light sensitivity
• Accelerated breathing
• Rectal pain
• Bile stones
• Hernia
• Wounds
• Weak or brittle nails
• Anomalous protein deposits in vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure
• Death

Side effects when given with other medicines for mantle cell lymphoma treatment

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

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

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

• Herpes zoster (localized including around the eyes or extended over the body)
• Herpes virus infection
• Bacterial and viral infections
• Respiratory infections, bronchitis, cough with mucus, flu-like illness
• Fungal infections
• Hypersensitivity (allergic reaction)
• Inability to produce sufficient insulin or resistance to normal insulin levels
• Fluid retention
• Difficulty or problems sleeping
• Loss of consciousness
• Alteration of level of consciousness, confusion
• 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 with exercise
• Cough
• Hypophonia
• Ringing in the ears, ear discomfort
• Intestinal or stomach bleeding
• Heartburn
• Abdominal or esophageal discomfort
• Difficulty swallowing
• Infection or inflammation of the stomach and intestines
• Gastralgia
• Mouth or lip sores, throat pain
• Alteration of liver function
• Itching skin
• Redness of the skin
• Rash
• Muscle spasms
• Urinary tract infections
• 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
• General feeling of being unwell
• Weight loss
• Weight gain

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

• Hepatitis
• Severe allergic reaction (anaphylactic reaction), whose signs can be difficulty breathing, chest pain or tightness and/or dizziness/fainting, intense itching skin or skin lumps, facial swelling, lips, tongue, and/or throat swelling, which can cause difficulty swallowing, collapse
• Movement disorders, paralysis, shakiness
• Dizziness
• Loss of hearing, deafness
• Lung disorders, preventing the body from receiving a sufficient amount of oxygen. Some of them are difficulty breathing, shortness of breath, shortness of breath without exercise, shallow, difficult or stopping breathing, rapid breathing
• Blood clots in the lungs
• Yellow discoloration of the eyes and skin (jaundice)
• Cyst on the eyelid (chalazion), red and swollen eyelids

Rare side effects(can affect up to 1 in 1,000 patients)

• Blood clot in small blood vessels (microangiopathy)

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

This medication does not require special temperature storage conditions.

Reconstituted solution

Chemical and physical stability during use has been demonstrated for 8days at 25°C and for 15 days at5± 3°Cin the dark, both in a vial and in a polipropylene syringe.

From a microbiological point of view, unless the reconstitution or dilution method excludes the risk of bacterial contamination, the medication should be used immediately. If not, the storage time and usage conditions are the responsibility of the user.

This medication is exclusively for single use.

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

Composition of Viatris Bortezomib

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

Reconstitution for intravenous administration:

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

Reconstitution for subcutaneous administration:

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

Appearance of Viatris Bortezomib and contents of the package

White or off-white powder or paste.

Viatris Bortezomib 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

Responsible for manufacturing

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 medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Last review date of this leaflet: March 2021

More detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

1.RECONSTITUTION FOR INTRAVENOUS ADMINISTRATION

Nota: Viatris Bortezomib is a cytotoxic agent. Therefore, caution should be exercised during manipulation and preparation. It is recommended to use gloves and other protective clothing to prevent skin contact.

AS Viatris Bortezomib DOES NOT CONTAIN PRESERVATIVES, STRICTLY FOLLOW ASPIRATION TECHNIQUE DURING ITS HANDLING.

1.1Preparation of a 3.5milligram vial: add 3.5milliliters of sterile 0.9percent sodium chloride solution to the vial containing the Viatris Bortezomib powder using a suitable syringe without removing the vial stopper. The dissolution of the lyophilized powder is completed in less than 2minutes.

The resulting solution concentration will be 1 milligram per milliliter. The solution must be colorless and transparent, with a final pH of 4 to 7. No pH check is required.

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

1.3The reconstituted solution lacks preservatives and should be used immediately after preparation. However, chemical and physical stability during use has been demonstrated for 8días at 25°C and for 15 días at 5 ± 3°C in the dark, in the original vial or syringe. From a microbiological point of view, unless the reconstitution or dilution method excludes the risk of bacterial contamination, the medicinal product should be used immediately. If not, the storage time and use conditions are the responsibility of the user.

2.ADMINISTRATION

• Once dissolved, remove the appropriate amount of the reconstituted solution according to 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 3-5second intravenous bolus, through a peripheral or central intravenous catheter in a vein.
• Wash the peripheral or intravenous catheter with sterile 0.9percent sodium chloride solution.

Viatris Bortezomib 3.5mg powder for injectable solution MUST BE ADMINISTERED ONLY BY SUBCUTANEOUS OR INTRAVENOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

3.ELIMINATION

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

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

This information is intended solely for healthcare professionals:

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

1.RECONSTITUTION FOR SUBCUTANEOUS ADMINISTRATION

Nota: Viatris Bortezomib is a cytotoxic agent. Therefore, caution should be exercised during manipulation and preparation. It is recommended to use gloves and other protective clothing to prevent skin contact.

AS Viatris Bortezomib DOES NOT CONTAIN PRESERVATIVES, STRICTLY FOLLOW ASPIRATION TECHNIQUE DURING ITS HANDLING.

1.1Preparation of a 3.5milligram vial: add 1.4milliliters of sterile 0.9percent sodium chloride solution to the vial containing the Viatris Bortezomib powder using a suitable syringe without removing the vial stopper. The dissolution of the lyophilized powder is completed in less than 2minutes.

The resulting solution concentration will be 2.5milligrams per milliliter. The solution must be colorless and transparent, with a final pH of 4 to 7. No pH check is required.

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

1.3The medicinal product reconstituted lacks preservatives and should be used immediately after preparation. However, chemical and physical stability during use has been demonstrated for 8días at 25°C and for 15 días at 5 ± 3°C in the dark, in the original vial or syringe. From a microbiological point of view, unless the reconstitution or dilution method excludes the risk of bacterial contamination, the medicinal product should be used immediately. If not, the storage time and use conditions are the responsibility of the user.

2.ADMINISTRATION

• Once dissolved, remove the appropriate amount of the reconstituted solution according to 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 must be rotated for subsequent injections.
• If local reactions occur at the injection site after a subcutaneous injection of this medicinal product, a less concentrated bortezomib solution (1mg/ml instead of 2.5mg/ml) can be administered subcutaneously or intravenously.

Viatris Bortezomib 3.5mg powder for injectable solution MUST BE ADMINISTERED BY SUBCUTANEOUS OR INTRAVENOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

3.ELIMINATION

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

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