Prospecto: information for the user

Bortezomib Waverley 3.5 mg powder for injectable solution EFG

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting touse Bortezomib Waverley

3.How to use Bortezomib Waverley

4.Possible adverse effects

5.Storage of Bortezomib Waverley

6.Contents of the package and additional information

This medication 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.

Bortezomibis 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 with thalidomide, in patients whose disease has not been previously treated and who are receiving high doses of chemotherapy prior to a stem cell transplant (induction treatment).

Bortezomibis 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.

No use Bortezomib Waverley

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

Warnings and Precautions

Consult your doctor or pharmacist if you experience any of the following:

• low red or white blood cell count
• bleeding problems and/or low platelet count in the 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 (localized, including around the eyes, or widespread)
• 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 recommend 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.

Inform your doctor if you have multiple myeloma and are receiving rituximab in combination with 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 experience repeated episodes 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 prospectuses of all medications you are using 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

Bortezomib should not be used in children and adolescents because its effects on them are unknown.

Other Medications and Bortezomib Waverley

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• ketoconazole, 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 to treat depression or other conditions,
• 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 bortezomib should use effective contraception during and for up to 3 months 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.

Thalidomide causes birth defects and fetal death. When bortezomib is administered in combination with thalidomide, follow the thalidomide pregnancy prevention program (see the thalidomide prospectus).

Driving and Operating Machinery

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 bortezomib based on your height and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg/m2of 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 appearance 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 (3-week) period 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 given along with pegylated liposomal doxorubicin, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and pegylated liposomal doxorubicin 30 mg/m2is administered on day 4 of the bortezomib 21-day treatment cycle by intravenous infusion after the bortezomib injection.

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

When bortezomib is given along with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and dexamethasone 20 mg is administered orally on days 1, 2, 4, 5, 8, 9, 11, and 12 of the bortezomiv 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 and are not a candidate for a blood stem cell transplant, you will receive bortezomib by intravenous injection 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 is administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, bortezomiv 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 any previous treatment for multiple myeloma andare a candidatefor a blood stem cell transplant, you will receive bortezomiv by intravenous or subcutaneous injection along with the medications dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When bortezomiv is given along with dexamethasone, you will receive bortezomiv by 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 bortezomiv 21-day treatment cycle.

You will receive 4 cycles (12 weeks).

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

Dexamethasone 40 mg is administered orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the bortezomiv 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 to 28, and from the second cycle and onwards, it may be increased further to 200 mg per day.

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

Untreated mantle cell lymphoma

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

Bortezomiv is administered by intravenous or subcutaneous 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 by intravenous infusion on day 1 of the bortezomiv 21-day treatment cycle:

Rituximab in doses of 375 mg/m2, cyclophosphamide in doses of 750 mg/m2, and doxorubicin in doses of 50 mg/m2.

Prednisone is administered orally in doses of 100 mg/m2on days 1, 2, 3, 4, and 5 of the bortezomiv treatment cycle.

How Bortezomiv Waverley is administered

This medication is administered by intravenous or subcutaneous injection. You will receive bortezomiv from a healthcare professional experienced in the use of cytotoxic medications.

The bortezomiv powder must be dissolved before administration. This will be done by a healthcare professional. The reconstituted solution is injected into a vein or under the skin. The injection into the vein is rapid, lasting between 3 and 5 seconds. The injection under the skin is administered in the thighs or abdomen.

If you receive more Bortezomiv Waverley 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some 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, regular blood tests will be performed before and during treatment with bortezomib to regularly check your blood cell count. You may experience a decrease in the number of:

• platelets, which may make you more prone to bruising (bruises), or bleeding without visible injury (e.g., 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 may 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 (may affect more than 1 in 10 patients)

• 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,
• nausea or vomiting, loss of appetite,
• constipation with or without swelling (may be severe),
• diarrhea: if it occurs, it is essential to drink more water than usual. Your doctor may give you another medicine to control diarrhea,
• fatigue, feeling weak,
• muscle pain, bone pain.

Common side effects (may affect up to 1 in 10 patients)

• low blood pressure, sudden drop in blood pressure when standing, which could lead to fainting,
• high blood pressure,
• kidney function impairment,
• headache,
• general feeling of discomfort, pain, dizziness, disorientation, feeling weak or loss of consciousness,
• chills,
• infections, including pneumonia, respiratory infections, bronchitis, fungal infections, cough with mucus, flu-like illness,
• shingles (localized including around the eyes or extended over the body),
• chest pain or difficulty breathing during exercise,
• different types of rashes,
• skin itching, skin lumps or dry skin,
• facial flushing or small blood vessel rupture,
• skin redness,
• dehydration,
• heartburn, swelling, belching, flatulence, stomach pain, intestinal or stomach bleeding,
• liver function impairment,
• mouth or lip sores, dry mouth, mouth ulcers or throat pain,
• weight loss, loss of taste,
• muscle cramps, muscle spasms, muscle weakness, limb pain,
• blurred vision,
• conjunctivitis (infection of the outer layer of the eye and the inner surface of the eyelids),
• nasal bleeding,
• 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.

Rare side effects (may affect up to 1 in 100 patients)

• heart failure, heart attack, chest pain, chest discomfort, sudden increase or decrease in heart rate,
• kidney failure,
• inflammation of a vein, blood clots in veins and lungs,
• blood clotting problems,
• poor circulation,
• inflammation of the heart lining or fluid around the heart,
• infections, including urinary tract infections, flu, herpes virus infection, ear infection, and cellulitis,
• membranous bleeding or hemorrhages in mucous membranes, for example, in the mouth or vagina,
• cerebrovascular disorders,
• paralysis, seizures, falls, movement disorders, changes or decrease in sensitivity (touch, hearing, taste, smell), attention disorders, tremors, convulsions,
• 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,
• hypo, speech disorders,
• increase or decrease in urine production (due to kidney damage), pain while urinating or blood/protein in the urine, fluid retention,
• change or loss of consciousness, confusion, memory loss,
• hypersensitivity,
• hearing loss, deafness or ringing in the ears, ear discomfort,
• hormonal changes that may affect salt and water absorption,
• hyperactivity of the thyroid gland,
• inability to produce sufficient insulin or resistance to normal insulin levels,
• eye irritation or inflammation, too moist eyes, eye pain, dry eyes, eye infections, chalazion, red and swollen eyelids, watery eyes, altered vision, eye hemorrhage,
• lymph node swelling,
• joint or muscle stiffness, feeling heavy, pain in the groin,
• hair loss 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,
• injection site or device-related problems,
• severe skin reactions (life-threatening), skin ulcers,
• bruises, falls, and injuries,
• inflammation or bleeding of small blood vessels that may appear as small red or purple spots (usually on the legs) to large patches similar to hematomas 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 (may affect up to 1 in 1,000 patients)

• heart problems, including heart attack, angina,
• severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome)
• flushing,
• venous discoloration,
• spinal nerve inflammation,
• ear problems, ear hemorrhage,
• hypothyroidism,
• Budd Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins),
• intestinal function changes or abnormalities,
• brain hemorrhage,
• yellow discoloration of the eyes and skin (jaundice),
• severe allergic reaction (anaphylactic shock), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense skin itching or skin lumps, facial swelling, lips, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse,
• breast disorders,
• vaginal tearing,
• genital inflammation,
• inability to tolerate alcohol consumption,
• demacración or weight loss,
• increased appetite,
• fistula,
• joint effusion,
• synovial cysts in the joint lining,
• fracture,
• muscle fiber breakdown leading to other complications,
• liver swelling, liver hemorrhage,
• kidney cancer,
• skin condition similar to psoriasis,
• skin cancer,
• skin paleness,
• increased platelets or plasma cells (a type of white blood cell) in the blood,
• blood clots in small blood vessels (microangiopathy),
• anomalous reaction to blood transfusions,
• partial or complete loss of vision,
• loss of libido,
• drooling,
• bulging eyes,
• light sensitivity,
• rapid breathing,
• rectal pain,
• gallstones,
• hernia,
• injuries,
• 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 side effects you may experience are listed below:

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

• 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 or vomiting,
• diarrhea,
• mouth ulcers,
• constipation,
• muscle pain, bone pain,
• hair loss and abnormal hair texture,
• fatigue, feeling weak,
• fever.

Common side effects (may affect up to 1 in 10 patients)

• shingles (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,
• change in level of consciousness, confusion,
• dizziness,
• increased heart rate, high blood pressure, sweating,
• altered vision, blurred vision,
• heart failure, heart attack, chest pain, chest discomfort, sudden increase or decrease in heart rate,
• high or low blood pressure,
• sudden drop in blood pressure when standing, which could lead to fainting,
• difficulty breathing during exercise,
• cough,
• hypo,
• 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,
• abdominal or esophageal pain,
• lip or mouth sores, throat pain,
• liver function impairment,
• skin itching,
• skin redness,
• rash,
• muscle spasms,
• urinary tract infections,
• limb pain,
• 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 discomfort,
• weight loss,
• weight gain.

Rare side effects (may affect up to 1 in 100 patients)

• hepatitis,
• severe allergic reaction (anaphylactic reaction), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense skin itching or skin lumps, facial swelling, lips, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse,
• movement disorders, paralysis, convulsions,
• dizziness,
• hearing loss, 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).
• chalazion, red and swollen eyelids.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist. Even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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.The expiration date refers to the last day of that month..

This medication does not require any special temperature conditions for storage..Store the vial in the outer packaging to protect it from light.

The reconstituted solution must be used immediately after preparation.If the reconstituted solution is not used immediately, the storage times after reconstitution and the conditions before use are the responsibility of the user.However, the reconstituted solution is stable for 8 hours at 25°C when stored in the original vial and 3 hours in a syringe, so the total storage time of the reconstituted medication should not exceed 8 hours in the vial and 3 hours in the syringe before administration.

Bortezomib Waverley3.5mg powder for injectable solution 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 ofBortezomib Waverley3.5 mg powder for solution for injection

- The active ingredient is bortezomib

Cada vial contains 3.5 milligrams of bortezomib (as boric acid mannitol ester).

- The other components are mannitol (E421)

Reconstitution for intravenous administration:

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

Reconstitution for subcutaneous administration:

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

What is the appearance of Bortezomib Waverley 3.5 mg powder for solution for injection and the contents of the packaging

Bortezomib Waverley 3.5 mg powder for solution for injection is a white or off-white paste or powder.

“Each container of Bortezomib Waverley 3.5 mg powder for solution for injection contains a 10 ml glass vial with a rubber stopper and an aluminum flip-off seal with a green plastic button.”

Marketing Authorization Holder

Waverley Pharma Europe Limited

Alexandra House, Office # 234, The Sweepstakes,

Ballsbridge, Dublin 4, D04 C7H2, Ireland

Manufacturer

UK:Mawdsley Brooks and Co. Ltd, Unit 22, Quest Park, Wheatley Hall Road, Doncaster DN2 4LT UK

EU:Wessling KFT, Anonymus u. 6, Hungary, Budapest 1045, Hungary

Wessling GmbH, Johann-Krane-Weg 42, 48149 Münster, Germany

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

Viso Farmacéutica, S.L.U

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names::

Last review date of this leaflet::September 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

The following information is only for healthcare professionals:

1. RECONSTITUTION FOR INTRAVENOUS ADMINISTRATION

Nota: bortezomib is a cytotoxic agent. Therefore, caution should be exercised during handling and preparation. Pregnant women should not handle this medication. It is recommended to use gloves and other protective clothing to prevent skin contact.

Since bortezomib lacks preservatives, it is recommended to follow a strict aseptic technique during its handling.

The resulting solution concentration will be 1 milligram/milliliter. The solution must be colorless and transparent, with a final pH of 4 to 7. The pH of the solution does not need to be checked.

The product reconstituted does not need to be protected from light.

1. 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 3-5 second intravenous bolus, through a peripheral or central intravenous catheter in a vein.

• Wash the peripheral or intravenous catheter with sterile sodium chloride 9 milligrams/milliliter (0.9%) injection solution.

BortezomibWaverley3.5 mg powder for solution for injection MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

1. ELIMINATION

A vial is for single use and the remaining solution must be discarded. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

The following information is only for healthcare professionals:

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

1. RECONSTITUTION FOR SUBCUTANEOUS ADMINISTRATION

PUESTO QUE BORTEZOMIB CARECE DE CONSERVANTES, SE ACONSEJA SEGUIR ESTRICTAMENTE UNA TÉCNICA ASÉPTICA DURANTE SU MANIPULACIÓN.

The resulting solution concentration will be 2.5 milligrams/milliliter. The solution must be colorless and transparent, with a final pH of 4 to 7. The pH of the solution does not need to be checked.

The product reconstituted does not need to be protected from light.

1. 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 thigh (right or left) or abdomen (right or left side).
• The administration sites should be rotated with each injection.
• If local reactions occur at the injection site after subcutaneous injection ofBortezomib Waverley3.5 mg powder for solution for injection, or a less concentrated solution ofBortezomib Waverley3.5 mg powder for solution for injection (1 mg/ml instead of 2.5 mg/ml) can be administered subcutaneously, or it is recommended to switch to intravenous injection.

BortezomibWaverley3.5 mg powder for solution for injection MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

1. ELIMINATION

A vial is for single use and the remaining solution must be discarded. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Nota: Bortezomib is a cytotoxic agent. Therefore, caution should be exercised during its handling and preparation. Pregnant women should not handle this medication. It is recommended to use gloves and other protective clothing to prevent skin contact.