2.5 mg / ml injection solution 
bortezomib

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Bortezomib STADA is and what it is used for 
2. What you need to know before you use Bortezomib STADA 
3. How to use Bortezomib STADA 
4. Possible side effects 
5. How to store Bortezomib STADA 6. Contents of the pack 
and other information 

What Bortezomib STADA is and what it is used for

Bortezomib Stada contains the active substance bortezomib, a so-called “proteasome inhibitor”. The proteasome plays an important role in controlling the function and growth of cells. By interfering with their function, bortezomib can kill cancer cells.

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

  • as a single drug or together with the drugs pegylated liposomal doxorubicin or dexamethasone to patients whose disease worsens (is progressive ) after receiving at least one previous treatment and where blood stem cell transplantation has not been successful or inappropriate.
  • in combination with the drugs melphalan and prednisone, for patients whose disease has not been previously treated and where high-dose chemotherapy with blood stem cell transplantation is not appropriate.
  • in combination with the drugs dexamethasone or dexamethasone together with thalidomide for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction therapy).

Bortezomib Stada is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients 18 years of age and older in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom stem cell transplantation is unsuitable.

Bortezomib contained in Bortezomib Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Bortezomib STADA

Do not use Bortezomib STADA

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

Warnings and cautions

Tell your doctor if you have any of the following:

  • low number of red or white blood cells
  • bleeding problems and / or low platelet count
  • diarrhea, constipation, nausea or vomiting
  • if you have a history of fainting or dizziness
  • kidney problems
  • moderate to severe liver problems
  • previous problems with numbness, tingling or pain in the hands or feet ( neuropathy )
  • heart problems or blood pressure et
  • shortness of breath or cough
  • seizures
  • shingles (which can occur locally, even around the eyes or be spread over the body)
  • symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or visual disturbances and shortness of breath
  • memory loss, difficulty thinking, difficulty walking or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further examinations and follow-up.

You must take regular blood tests before and during treatment with Bortezomib Stada to check the number of blood cells .

Tell your doctor if you have mantle cell lymphoma and are taking rituximab with Bortezomib Stada:

  • if you think you have a liver infection ( hepatitis ) now or if you have had it before. In a few cases, patients who have had hepatitis B have had hepatitis again, which can be fatal. If you have had hepatitis B before, you will be closely monitored by your doctor for signs of active hepatitis B.

You must read the package leaflets for all medicines taken with Bortezomib Stada for information on these medicines before starting treatment with Bortezomib Stada. When thalidomide is used, special attention should be paid to pregnancy testing and contraception (see Pregnancy and breast-feeding in this section).

Children and young people

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

Other medicines and Bortezomib STADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

  • ketoconazole , which is 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 diabetes medicine.

Pregnancy, breastfeeding and fertility

You should only use Bortezomib Stada during pregnancy if absolutely necessary.

Both men and women should use effective contraception during and for three months after treatment with Bortezomib Stada. If pregnancy still occurs, consult a doctor immediately.

You should not breast-feed during treatment with Bortezomib Stada. Ask your doctor when it is safe to start breast-feeding again after stopping treatment.

Thalidomide causes birth defects and fetal death. When Bortezomib Stada is taken with thalidomide, you must follow the thalidomide prevention program to prevent pregnancy (see the thalidomide package leaflet).

Driving and using machines

Bortezomib Stada may cause fatigue, dizziness, fainting and blurred vision. Do not drive or use any tools or machines if you experience any of these symptoms and even if you do not feel any symptoms, caution should be exercised.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bortezomib STADA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial , ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Bortezomib STADA

Your doctor will calculate the appropriate dose of Bortezomib Stada using your height and weight (body surface area). The usual starting dose of Bortezomib Stada is 1.3 mg / m 2 body surface area twice a week. Your doctor may change the dose and the number of rounds of treatment depending on how you respond to the treatment, if you get certain side effects and your underlying illnesses (eg liver problems).

Progressive multiple myeloma

When you receive Bortezomib Stada as a single drug, you will receive 4 doses of bortezomib Stada intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ten-day treatment break. This 21-day period (3 weeks) corresponds to one round of treatment. You can receive up to 8 rounds of treatment (24 weeks).

You can also receive Bortezomib Stada with the medicines pegylated liposomal doxorubicin or dexamethasone.

When Bortezomib Stada is co-administered with pegylated liposomal doxorubicin, you will receive Bortezomib Stada intravenously or subcutaneously in a 21-day treatment cycle, and pegylated liposomal doxorubicin 30 mg / m 2 will be given on day 4 of the 21-day treatment cycle with Bortezomib Stada, in the form of a drop, in a friend after injection one with Bortezomib Stada. You can receive up to 8 rounds of treatment (24 weeks).

When Bortezomib Stada is given with dexamethasone, you will receive Bortezomib Stada intravenously or subcutaneously in a 21-day treatment cycle, and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of the 21-day treatment cycle with Bortezomib Stada. You can receive up to 8 rounds of treatment (24 weeks).

Previously untreated multiple myeloma

If you have not previously been treated for multiple myeloma , and you are not suitable for blood stem cell transplantation, you will be given Bortezomib Stada along with two other medicines: melphalan and prednisone.

In this case, a course of treatment lasts for 42 days (6 weeks). You will receive a total of 9 rounds of treatment (54 weeks).

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

Both melphalan (9 mg / m 2 ) and prednisone (60 mg / m 2 ) are taken orally on days 1, 2, 3 and 4 during the first week of each treatment cycle.

If you have not previously been treated for multiple myeloma , and if you are suitable for a blood stem cell transplant, you will receive Bortezomib Stada intravenously or subcutaneously with the medicines dexamethasone or dexamethasone and thalidomide, as induction therapy.

When Bortezomib Stada is given with dexamethasone, you will receive Bortezomib Stada intravenously or subcutaneously in a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the 21-day treatment cycle days with Bortezomib Stada. You will receive 4 rounds of treatment (12 weeks).

When Bortezomib Stada is co-administered with thalidomide and dexamethasone, the duration of treatment is 28 days (4 weeks).

Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of 28 days of treatment with Bortezomib Stada, and thalidomide is given orally daily with 50 mg until day 14 of the first treatment cycle. and if you tolerate the thalidomide dose,increase the dose one to 100 mg on days 15-28 and then increase it to 200 mg daily from the second round of treatment. You can receive up to 6 rounds of treatment (24 weeks).

Previously untreated mantle cell lymphoma

If you have not previously been treated for mantle cell lymphoma, you will receive Bortezomib Stada intravenously or subcutaneously with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.

Bortezomib Stada is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a “rest period” without treatment. The treatment cycle lasts 21 days (3 weeks). You can receive up to 8 rounds of treatment (24 weeks).

The following medicines are given as an intravenous infusion on day 1 of each 21-day course of treatment with Bortezomib Stada:

Rituximab 375 mg / m 2 , cyclophosphamide 750 mg / m 2 and doxorubicin 50 mg / m 2 .

Prednisone 100 mg / m 2 is given orally (orally) on days 1, 2, 3, 4 and 5 of the Bortezomib Stada treatment cycle.

How Bortezomib Stada is given

This medicine is for subcutaneous use and after dilution also for intravenous use. Bortezomib Stada will be given by healthcare professionals experienced in the use of cytotoxic drugs.

The solution is injected either into a vein or under the skin. Injection into a vein is fast and takes 3-5 seconds. Injection under the skin is given either in the thighs or in the abdomen.

If you use more Bortezomib STADA than you should 

Because you are receiving this medicine from a doctor or nurse, it is unlikely that you will receive too much. If you are unlikely to get an overdose, your doctor will monitor you for side effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious.

If you get Bortezomib Stada for multiple myeloma or mantle cell lymphoma, tell your doctor immediately if you notice any of the following symptoms:

  • muscle cramps, muscle weakness
  • confusion, loss of vision or visual disturbances, blindness, seizures, headache
  • shortness of breath, swollen feet or changes in your heartbeat, high blood pressure, fatigue, fainting
  • coughing and difficulty breathing or that the chest feels tight.

It is very common that treatment with Bortezomib Stada causes a reduction in the number of red and white blood cells and platelets . Therefore, you must take regular blood tests before and during treatment with Bortezomib Stada to check the number of blood cells . You can get a reduced number:

  • platelets , which may make you more likely to get bruises, or bleeding for no apparent reason (eg bleeding from the intestines, stomach, mouth or gums or bleeding in the brain or bleeding from the liver)
  • red blood cells , which can cause anemia with symptoms such as fatigue and pallor
  • white blood cells , which may make you more likely to get infection or flu-like symptoms .

If you get Bortezomib Stada for multiple myeloma , you can get the side effects listed below:

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

  • sensitivity, numbness, tingling or burning in the skin, or pain in the hands or feet, due to nerve damage
  • reduction in the number of red blood cells and / or white blood cells (see above)
  • fever
  • nausea or vomiting, loss of appetite
  • constipation with or without bloating (can be severe)
  • Diarrhea: If this happens, it is important that you drink more water than usual. Your doctor may give you another medicine for diarrhea
  • fatigue, feeling of weakness
  • muscle pain, skeletal pain.

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

  • low blood pressure , sudden drop in blood pressure when you get up which can cause you to faint
  • high blood pressure
  • renal impairment
  • headache
  • general malaise, pain, dizziness, fainting, lethargy or loss of consciousness
  • shaking
  • infection including pneumonia , respiratory tract infections, tracheitis , fungal infections, cough with mucus, flu-like conditions
  • shingles (which can occur locally, even around the eyes, or be spread over the body)
  • chest pain or shortness of breath during physical exertion
  • different types of rash
  • itchy skin, lumps of skin or dry skin
  • flushing or small ruptured capillaries
  • reddening of the skin
  • dehydration
  • heartburn, bloating, belching, gas, abdominal pain, bleeding from the intestines or stomach
  • altered liver function
  • soreness in the mouth or lips, dry mouth , cold sores or sore throat
  • weight loss, loss of taste
  • muscle cramps, muscle spasms, muscle weakness, pain in arms/legs
  • dimsyn
  • infection in the outer membrane of the eye and in the inner surface of the eyelids (conjunctivitis)
  • nosebleeds
  • difficulty sleeping, sweating, anxiety, mood swings, depression, restlessness or anxiety, changes in mental health, disorientation
  • swelling of the body including swelling 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, chest discomfort, increased or decreased heart rate
  • kidney failure
  • inflammation of a blood vessel, blood clots in blood vessels or lungs
  • problems with blood clotting ability
  • insufficient circulation
  • inflammation of the pericardium or fluid around the heart
  • infection including urinary tract infections, flu, herpes infections, ear infections, and inflammation of the subcutaneous tissue ( cellulite )
  • bloody stools or bleeding in mucous membranes in, for example, the mouth, abdomen
  • diseases of the blood vessels of the brain
  • paralysis, seizures, falls, movement disorders, abnormalities or changes in or decreased sensations (feeling, hearing, taste, smell), attention deficit disorder, tremors, muscle twitching
  • joint inflammation, including inflammation of the joints of the fingers, toes and jaw
  • Disorders that affect your lungs prevent your body from getting enough oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without physical exertion, breathing that becomes shallow, strenuous or paused breathing, wheezing
  • hiccups, speech disorders
  • increased or decreased urine output (due to kidney damage), pain when urinating or blood/protein in the urine, fluid retention
  • altered level of consciousness, confusion, impaired memory or memory loss
  • hypersensitivity
  • hearing loss, deafness or wheezing in the ears, discomfort in the ears
  • disturbances in the hormonal balance that can affect the uptake of salt and water
  • overactive thyroid gland
  • inability to produce enough insulin or resistance to normal insulin levels
  • irritated or inflamed eyes, excessively moist eyes, eye pain, dry eyes, eye infections , chalazion , red and swollen eyelids, discharge from the eyes, blurred vision, bleeding from the eyes
  • swollen lymph nodes
  • stiffness in joints or muscles, feeling of heaviness, pain in the groin
  • hair loss and abnormal hair structure
  • allergic reactions
  • redness or pain at the injection site
  • pain in the mouth
  • infection or inflammation of the mouth, cold sores, infection of the esophagus, stomach and intestines sometimes associated with pain and bleeding, weak bowel movements (including total stop), discomfort in the stomach or esophagus, difficulty swallowing, vomiting of blood
  • skin infections
  • bacterial and viral infections
  • dental infections
  • inflammation of the pancreas, stasis in the bile duct
  • genital pain, difficulty getting an erection
  • weight gain
  • thirst
  • hepatitis
  • complications related to the injection site or intravenous entry
  • skin reactions and skin diseases (which can be serious and life-threatening), skin ulcers
  • bruises, falls and injuries
  • inflammation or bleeding in blood vessels that can occur as anything from small red or purple dots (usually on the legs) to large bruise-like spots under the skin or tissue a
  • benign cysts
  • a severely reversible condition of the brain that includes seizures, high blood pressure , headaches, fatigue, confusion, blindness or other visual disturbances.

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

  • heart problems including heart attack, angina
  • redness
  • discoloration of the veins
  • inflammation of the spinal nerves
  • ear problems, bleeding in the ears
  • decreased activity of the thyroid gland
  • Budd-Chiaris syndrome (the clinical symptoms are caused by a blockage of the hepatic veins)
  • changes in or abnormal bowel functions
  • cerebral haemorrhage
  • yellowing of the eyes and skin (jaundice)
  • signs of severe allergic reaction (anaphylactic shock ) such as difficulty breathing, chest pain or pressure over the chest and / or feeling dizzy / fainting, severe itching or raised lumps in the skin, swelling of the face, lips, tongue and / or throat, which may cause swallowing difficulties, collapse
  • breast disorders
  • vaginal ulcers
  • swollen genitals
  • inability to tolerate alcohol
  • weight loss
  • increased appetite
  • fistula
  • joint ejection
  • cysts in the synovium (synovial cyst)
  • fracture is
  • degradation of muscle fibers leading to other complications
  • swelling of the liver, bleeding from the liver
  • kidney cancer
  • psoriasis-like skin problems
  • skin cancer
  • pale skin
  • increase in platelets or plasma cells (a type of white blood cell ) in the blood
  • abnormal response to blood transfusion is
  • partial or total vision loss
  • decreased sex drive
  • dredging
  • protruding eyes
  • photosensitivity
  • rapid breathing
  • rectal pain
  • gallstones ar
  • hernia
  • injuries
  • fragile or weak nails
  • Abnormal precipitation of protein is in your vital organs
  • coma
  • intestinal ulcers
  • failure of several organs simultaneously
  • death blood clot in small blood vessels (thrombotic microangiopathy).

If you are receiving Bortezomib Stada together with other medicines for the treatment of mantle cell lymphoma, you may experience the side effects listed below:

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

  • pneumonia
  • reduced appetite
  • sensitivity, numbness, tingling or burning in the skin, or pain in the hands or feet due to nerve damage
  • nausea and vomiting
  • diarrhea
  • cold sores
  • constipation
  • muscle pain, skeletal pain
  • hair loss and abnormal hair structure
  • fatigue, feeling of weakness
  • fever.

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

  • shingles (which can occur locally, even around the eyes or be spread over the body)
  • herpes infections
  • bacterial and viral infections
  • respiratory tract infections, bronchitis, cough with mucus, flu-like illness
  • fungal infections
  • hypersensitivity ( allergic reaction )
  • inability to produce enough insulin or resistance to normal insulin levels
  • fluid retention
  • sleeping problems
  • unconsciousness
  • altered level of consciousness, confusion
  • dizziness
  • faster heartbeat, high blood pressure, sweating
  • abnormal syn, dimsyn
  • heart failure , heart attack, chest pain, chest discomfort, increased or decreased heart rate
  • high or low blood pressure
  • sudden drop in blood pressure when you get up which can cause you to faint
  • shortness of breath on exertion
  • cough
  • hiccup
  • ringing in the ears, discomfort in the ears
  • bleeding from the intestines or stomach
  • heartburn
  • abdominal pain, bloating
  • difficulty swallowing
  • infection or inflammation of the stomach or intestines
  • abdominal pain
  • soreness in the mouth or lips, sore throat
  • altered liver function
  • skin itching
  • reddening of the skin
  • rash
  • muscle spasms
  • urinary tract infections
  • pain in arms and legs
  • swelling in the body, which also includes the eyes and other parts of the body
  • overindulge
  • redness and pain at the injection site
  • general malaise
  • weight loss
  • weight gain.

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

  • hepatitis
  • signs of severe allergic reaction (anaphylactic shock ) such as difficulty breathing, chest pain or pressure over the chest and / or feeling dizzy / fainting, severe itching or raised lumps in the skin, swelling of the face, lips, tongue and / or throat, which may cause swallowing difficulties, collapse
  • movement disorders, paralysis, muscle twitching
  • dizziness
  • hearing loss, deafness
  • Disorders that affect your lungs prevent your body from getting enough oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without physical exertion, breathing that becomes shallow, strenuous or paused breathing, wheezing
  • blood clots in the lungs
  • yellowing of the eyes and skin (jaundice)
  • lump on the eyelid ( chalazion ), red and swollen eyelids.

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

  • blood clot in small blood vessels (thrombotic microangiopathy).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bortezomib STADA

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

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.

Store unopened vial in refrigerator (2 o C-8 o C). Keep the vial in the outer carton. Sensitive to light.

Diluted solution should be used immediately. If the diluted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the diluted solution is chemically and physically stable for 28 days at 2 – 8 ° C protected from light, 7 days at 25 ° C protected from light or 24 hours at 25 ° C (under normal indoor lighting conditions) when stored in the original bottle and/or a polypropylene syringe.

For stability of the vial and / or syringe, the same storage life applies to the diluted solution and the undiluted solution.

This medicine is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bortezomib. Each vial contains 1.4 ml solution for injection containing 3.5 mg bortezomib (as a mannitol-boronic acid ester).
  • The other ingredients are mannitol, sodium chloride and water for injections.

Intravenous use: after dilution, 1 ml of intravenous solution for injection contains 1 mg bortezomib.

Subcutaneous use: 1 ml solution for subcutaneous injection contains 2.5 mg bortezomib.

What the medicine looks like and the contents of the pack

Bortezomib Stada is a clear and colorless to light yellow solution.

Each carton of Bortezomib Stada 2.5 mg / ml solution for injection contains a 10 ml glass vial with a yellow polypropylene flip-off cap.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2–18

61118 Bad Vilbel

Germany

Other manufacturers

STADAPHARM GmbH

Feodor-Lynen-Straße 35

Hannover 30625, Germany

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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