10 mg powder for infusion, 30 mg powder for infusion, 60 mg powder for infusion solution
carfilzomib

What Kyprolis is and what it is used for

Kyprolis is a medicine that contains the active substance carfilzomib.

Carfilzomib works by blocking the proteasome. The proteasome is a system inside the cells that breaks down proteins that are damaged or no longer needed. Cancer cells generally contain larger amounts of abnormal proteins than healthy cells and by preventing these proteins from being broken down in the cancer cells, Kyprolis can cause cell death in the cancer cells.

Kyprolis is used to treat adult patients with myeloma who have received at least one previous treatment for this disease. Myeloma is a form of cancer that occurs in plasma cells (a type of white blood cell ).

You will receive Kyprolis with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone. Daratumumab, lenalidomide, and dexamethasone are other medicines used to treat myeloma.

What you need to know before using Kyprolis

Do not use Kyprolis

The doctor will examine you and go through your entire previous medical history. You will be closely monitored during treatment. Before you start taking Kyprolis and during treatment, you will have to submit blood samples. The samples are used to check that you have enough blood cells and that the liver and kidneys are functioning properly. Your doctor or nurse will check that you are getting enough fluids.

Read the package leaflet for all the medicines you are taking in combination with Kyprolis so that you understand the information regarding these medicines.

Do not use Kyprolis if you are allergic to carfilzomib or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or nurse before using Kyprolis if you have any of the conditions listed below. You may need to undergo additional tests to check that your heart, kidneys, and liver are working properly.

  • Heart problems, if you e.g. have previously had chest pain (angina), heart attack or irregular heartbeat, high blood pressure , or if you have ever used any heart medicine.
  • Lung problems, if you e.g. previously had shortness of breath at rest or activity ( dyspnoea ).
  • Kidney problems, if you e.g. have kidney failure or if you have ever had dialysis .
  • Liver problems, if you e.g. have previously had hepatitis or fatty liver , or if you have ever been told that your liver is not working properly.
  • Unusual bleeding, e.g. if you get bruises very easily or if it takes an unusually long time before it stops bleeding from an injury, such as a cut or internal bleeding such as bloody coughs, bloody vomiting, dark tar-like stools or light red blood in the stools; or bleeding in the brain leading to sudden numbness or paralysis in one side of the face, arms or legs, sudden severe headache, vision problems or speech or swallowing difficulties. This may indicate that you have too few platelets (cells that help the blood to clot).
  • If you have had blood clots in your veins before.
  • Pain or swelling in the legs or arms (which may be a symptom of blood clots in the deep veins of the legs or arms), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs).
  • Any other type of illness for which you have been hospitalized or have received medication.

Symptoms that you should be aware of

You need to be aware of certain symptoms while you are taking Kyprolis to reduce the risk of any problems. Kyprolis can aggravate certain conditions and cause serious side effects, which can be fatal, e.g. heart problems, lung problems, kidney problems, tumor lysis syndrome (a life-threatening condition that occurs when the cancer cells are destroyed and release their contents into the blood), reactions to the Cyprolis infusion (drip), unusual bruising or bleeding, (including internal bleeding), blood clots in the veins, liver problems, some blood-related conditions, or a neurological condition called PRES (posterior reversible encephalopathy syndrome). See “Symptoms to be aware of” in section 4.

Tell your doctor if you have or currently have a hepatitis B infection. This is because this medicine may cause the hepatitis B virus to reactivate. Your doctor will examine you and look for signs of this infection before, during, and for some time after treatment with this medicine. Tell your doctor immediately if you get tired or if your skin or whites of your eyes turn yellow.

Tell your doctor or nurse immediately if at any time during or after treatment you have blurred vision, blurred vision or double vision, difficulty speaking, weakness in an arm or leg, an altered gait or balance problems, persistent numbness, impaired or lost sensation, memory loss or confusion. These can all be symptoms of a serious and potentially life-threatening condition in the brain called progressive multifocal leukoencephalopathy (PML). If you have these symptoms before treatment with carfilzomib, tell your doctor if your symptoms change.

Other medicines and Kyprolis

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines such as vitamins or herbal medicines.

Tell your doctor or nurse if you are taking medicines used to prevent pregnancy, such as birth control pills or other hormonal contraceptives, as these may not be suitable for use with Kyprolis.

Pregnancy and breastfeeding

For women using Kyprolis

Do not use Kyprolis if you are pregnant, think you may be pregnant, or are planning to have a baby. Treatment with Kyprolis has not been evaluated in pregnant women. While you are using Kyprolis and for 30 days after stopping treatment, use an appropriate method of contraception to ensure that you do not become pregnant. Talk to your doctor or nurse about appropriate contraceptive methods.

If you become pregnant while taking Kyprolis, tell your doctor or nurse immediately.

Do not use Kyprolis if you are breastfeeding. It is not known if Kyprolis passes into breast milk.

Lenalidomide is expected to be harmful to the unborn baby. Because Kyprolis is given in combination with lenalidomide, you must follow the pregnancy prevention program available for this medicine (see the lenalidomide leaflet for information on contraception and consult a doctor, pharmacist, or nurse).

For men using Kyprolis

During the time you use Kyprolis and for 90 days after you have stopped the treatment, you should use a condom even if your partner is pregnant.

If your partner becomes pregnant while you are taking Kyprolis or within 90 days of stopping treatment, tell your doctor or nurse immediately.

Driving and using machines

While you are being treated with Kyprolis, you may experience fatigue, dizziness, fainting, and/or a drop in blood pressure. This may impair your ability to drive or use machines. Do not drive or use machines if you have these symptoms.

Kyprolis contains sodium

This medicine contains 37 mg sodium per 10 mg vial. This corresponds to 1.9% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).

This medicine contains 109 mg of sodium per 30 mg vial. This corresponds to 5.5% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).

This medicine contains 216 mg of sodium per 60 mg vial. This corresponds to 11% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).

Kyprolis contains cyclodextrin

This medicine contains 500 mg cyclodextrin (sulfobutylbetadex sodium) per 10 mg vial . This is equivalent to 88 mg / kg for an adult weighing 70 kg.

This medicine contains 1,500 mg of cyclodextrin (sulfobutylbetadex sodium) per 30 mg vial . This is equivalent to 88 mg / kg for an adult weighing 70 kg.

This medicine contains 3,000 mg of cyclodextrin (sulfobutylbetadex sodium) per 60 mg vial . This is equivalent to 88 mg / kg for an adult weighing 70 kg.

How to use Kyprolis

You will receive Kyprolis from a doctor or nurse. Dose one will be calculated based on height and weight (your body surface area). Your doctor or nurse will decide what dose of Kyprolis you should receive.

Kyprolis will be given as an infusion (drip) into a vein. Infusion can last for up to 30 minutes. Kyprolis is given 2 days in a row, every week for 3 weeks. This is followed by a week without treatment.

Each 28 ‑ day period is one treatment cycle. This means that you will receive Kyprolis on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Dose limits on days 8 and 9 of each cycle will be excluded from cycle 13 on treatment with Kyprolis in combination with lenalidomide and dexamethasone.

Most patients will be treated as long as the disease improves or remains stable. However, treatment with Kyprolis may also be discontinued if you experience side effects that cannot be controlled.

Along with Kyprolis, you will also receive either lenalidomide and dexamethasone, daratumumab and dexamethasone, or dexamethasone alone. You can also get other medicines.

If you use more Kyprolis than you should  

Because you are receiving this medicine from a doctor or nurse, it is unlikely that you will receive too much. However, should this happen, your doctor will monitor you for side effects.

If you have any further questions on the use of this product, ask your doctor or nurse.

Possible side effects

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

Symptoms that you should be aware of

Some side effects can be serious. Contact a doctor immediately if you get any of the following symptoms:

  • Chest pain, shortness of breath or swollen feet, these can be symptoms of heart problems.
  • Breathing difficulties, including shortness of breath at rest or activity or coughing, rapid breathing, a feeling that you are not getting enough air, wheezing or coughing, these can be signs of lung problems.
  • Very high blood pressure , severe chest pain, severe headache, confusion, blurred vision, nausea and vomiting, or severe anxiety, these can be signs of a condition called hypertensive crisis.
  • Shortness of breath during everyday activities or at rest, irregular heartbeats, rapid heart rate , fatigue, dizziness and fainting spells, these can be signs of a condition called pulmonary hypertension .
  • Swollen ankles, feet or hands, loss of appetite, less urine than normal or abnormal blood test results, these can be symptoms of kidney problems or kidney failure .
  • A side effect called tumor lysis syndrome, which can be caused by rapid breakdown of tumor cells and which can give rise to irregular heartbeat, kidney failure or abnormal blood test results.
  • Fever, chills, joint pain, muscle aches, flushing or swelling of the face, lips, tongue and / or throat which may make it difficult to breathe and swallow ( angioedema ), weakness, shortness of breath, low blood pressure , fainting, slow pulse , feeling of tightness in the chest or chest pain, which may be a reaction to infusion one.
  • Unusual bruising or bleeding, such as a cut that takes an unusually long time to stop bleeding or internal bleeding such as bloody coughs, bloody vomiting, dark tar-like stools or light red blood in the stools; or bleeding in the brain leading to sudden numbness or paralysis in one side of the face, arms or legs, sudden severe headache, vision problems or speech or swallowing difficulties.
  • Pain or swelling in the legs or arms (which may be a symptom of blood clots in the deep veins of the legs or arms), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs).
  • Yellowing of the skin and whites of the eyes (jaundice), abdominal pain or swelling, nausea or vomiting, which may be symptoms of liver problems, including liver failure. If you have previously had a hepatitis B infection , treatment with this medicine may cause the hepatitis B infection to become active again.
  • Bleeding, bruising, weakness, confusion, fever, nausea, vomiting and diarrhea and acute renal failure , these can be signs of a blood disease called thrombotic microangiopathy.
  • Headache, confusion, seizures, loss of vision and high blood pressure ( hypertension ), which may be symptoms of a neurological condition called PRES (posterior reversible encephalopathy syndrome).

Other possible side effects are

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

  • Severe pneumonia ( pneumonia )
  • Respiratory tract infections
  • Low platelet count , which may cause bruising or bleeding ( thrombocytopenia )
  • Low white blood cell count , which may reduce your ability to fight infection and may be associated with fever
  • Low red blood cell count ( anemia ), which can cause fatigue and tiredness
  • Altered blood test values ​​(decreased potassium levels in the blood, elevated levels of creatinine in the blood)
  • Decreased appetite
  • Difficulty sleeping (insomnia)
  • Headache
  • Numbness, tingling or decreased sensation in hands and / or feet
  • Dizziness
  • High blood pressure ( hypertension )
  • Respiratory distress
  • Cough
  • Diarrhea
  • Nausea
  • Constipation
  • Vomiting
  • Stomach pain
  • Back pain
  • Joint pain
  • Pain in arms, legs, hands or feet
  • Muscle spasms
  • Fever
  • Overindulge
  • Swollen hands, feet or ankles
  • Feeling weak
  • Fatigue (exhaustion)

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

  • Infusion reactions
  • Heart failure and heart problems, including fast, heavy, or irregular heartbeat
  • Myocardial infarction
  • Kidney problems, including kidney failure
  • Blood clots in the veins (deep vein thrombosis )
  • A feeling of being too hot
  • Blood clots in the lungs
  • Fluid in the lungs
  • Wheezing
  • Serious infection you, including infection in the blood ( sepsis )
  • Lung infection
  • Liver problems, including elevated liver values ​​in blood test analyzes
  • Flu-like symptoms 
  • Reactivation of chickenpox virus, which can cause skin rash and pain ( shingles )
  • Urinary tract infection
  • Cough that can also occur together with a feeling of tightness or pain in the chest and nasal congestion ( bronchitis )
  • Sore throat
  • Inflammation of the nose and throat
  • Runny nose, nasal congestion or sneezing
  • Virus infection
  • Infection of the stomach or intestines ( gastroenteritis )
  • Bleeding in the stomach or intestines
  • Altered blood test values ​​(decreased levels of sodium , magnesium , protein , calcium or phosphate in the blood, elevated levels of calcium , uric acid , potassium , bilirubin , c-reactive protein or blood sugar)
  • Dehydration
  • Anxiety 
  • Confusion
  • Dimsyn
  • Cataract
  • Low blood pressure ( hypotension )
  • Nosebleed
  • Altered voice or hoarseness
  • Digestive problems
  • Toothache
  • Rash
  • Skeletal pain, muscle pain, chest pain
  • Muscle weakness
  • Painful muscles
  • Skin itching
  • Reddening of the skin
  • Increased sweating
  • Pain
  • Pain, swelling, irritation or discomfort at the injection site
  • Ringing in the ears ( tinnitus )
  • General malaise or discomfort

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

  • Bleeding in the lungs
  • Colon inflammation caused by a bacterium called Clostridium difficile
  • Allergic reactions to Kyprolis
  • Multi-organ failure
  • Reduced blood flow to the heart
  • Bleeding in the brain
  • Stroke
  • Breathing difficulties, rapid breathing and / or bluish fingertips and lips (respiratory distress syndrome)
  • Swelling of the pericardium (pericarditis) with symptoms such as pain under the sternum, which sometimes spreads to the neck and shoulders, sometimes with fever
  • Accumulation of fluid in the pericardium (pericardial effusion) with symptoms such as chest pain or pressure over the chest and shortness of breath
  • Blockage of bile flow from the liver (cholestasis), which can cause itchy skin, yellowish skin, very dark urine and very pale stools
  • Small holes ( perforation ) in the digestive tract
  • Cytomegalovirus infection
  • Reactivation of hepatitis B infection (viral inflammation of the liver)
  • Inflammation of the pancreas

How to store Kyprolis

Kyprolis will be stored at the pharmacy.

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. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

The finished product must be clear, colorless to slightly yellowish, and must not be administered if any discoloration or particles are observed.

Kyprolis is for single use only. Any unused product or waste material should be disposed of by local requirements.

Contents of the pack and other information

Content declaration

  • The active substance is carfilzomib. One vial contains 10 mg, 30 mg or 60 mg carfilzomib. After reconstitution , 1 ml of solution contains 2 mg of carfilzomib.
  • The other ingredients are betadex-sulfobutyl ether sodium , anhydrous citric acid (E330) and sodium hydroxide (see section 2 “Kyprolis contains sodium”).

What the medicine looks like and contents of the pack

Kyprolis is supplied in a glass vial as a white to off-white powder for solution for infusion, which is dissolved before use. The reconstituted solution is a clear, colorless to pale yellow solution.

One pack contains a vial.

Marketing Authorization Holder and Manufacturer

Amgen Europe BV

Minervum 7061,

4817 ZK Breda,

Netherlands

Muhammad Nadeem

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