Bendeka is used to treat chronic lymphocytic leukemia. This medicine is also used to treat indolent B-cell non-Hodgkin lymphoma after other medicines have been tried without successful treatment of this condition.

Bendeka may also be used for purposes not listed in this medication guide.

Bendeka side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Bendeka may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Bendeka may cause serious side effects. Call your doctor at once if you have:

• fever, chills, or itching during or shortly after the injection;
• pain, swelling, redness, skin changes, or signs of infection where the medicine was injected;
• severe ongoing nausea, vomiting, or diarrhea;
• liver problems–right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• signs of tumor cell breakdown–confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed if you have certain side effects.

Common side effects of Bendeka may include:

• fever, cough, mouth sores, trouble breathing;
• low blood cell counts;
• nausea, vomiting, diarrhea, constipation;
• headache, tiredness;
• rash; or
• loss of appetite, weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Tell your caregivers right away if you have any type of skin rash after being treated with Bendeka.

Before taking this medicine

You should not be treated with Bendeka if you are allergic to Bendeka, polyethylene glycol, propylene glycol, or mannitol (Osmitrol).

Tell your doctor if you have ever had:

• a weak immune system;
• fever or other signs of infection;
• tuberculosis;
• herpes zoster (also called shingles)
• a metabolic disorder or electrolyte imbalance;
• liver disease;
• kidney disease; or
• if you smoke.

Using Bendeka may increase your risk of developing certain types of cancer. Ask your doctor about this risk.

Bendeka can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Bendeka if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Bendeka.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because Bendeka can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How is Bendeka given?

Bendeka is given as an infusion into a vein. A healthcare provider will give you this injection.

Bendeka is usually given for 2 days in a row every 21 to 28 days. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to help prevent certain side effects of bendamustine.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Bendeka affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

What is Leukeran?

Leukeran is used to treat several types of cancer, including Hodgkin’s disease and certain types of leukemia or lymphoma.

Leukeran may also be used for purposes not listed in this medication guide.

Leukeran side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Leukeran may cause serious side effects. Call your doctor at once if you have:

• a seizure;
• an unusual mass or lump;
• severe vomiting or diarrhea;
• new or worsening cough;
• bone marrow suppression–dizziness, pale lips or fingernail beds, fast heart rate, getting easily tired or short of breath;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of Leukeran may include:

• bone marrow suppression;
• low blood cell counts;
• missed menstrual periods;
• nausea, vomiting, diarrhea; or
• sores or white patches in or around your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Leukeran can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, weakness).

Before taking this medicine

You should not be treated with Leukeran if you are allergic to it, or if you have received this medicine in the past without successful treatment of your condition.

You may not be able to receive Leukeran if you’ve ever had an allergic reaction to another cancer drug such as bendamustine, busulfan, carmustine, dacarbazine, ifosfamide, lomustine, mechlorethamine, melphalan, streptozocin, or temozolomide.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• a seizure;
• a head injury or brain tumor; or
• if you have received radiation or chemotherapy within the past 4 weeks.

Taking Leukeran may increase your risk of developing other types of cancer. Talk to your doctor about your specific risk.

Do not use Leukeran if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using Leukeran.

This medicine may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy because Leukeran can harm an unborn baby.

You should not breastfeed while using this medicine.

How should I take Leukeran?

You must remain under the care of a doctor while you are using Leukeran.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Leukeran is usually taken for 3 to 6 weeks. Follow your doctor’s dosing instructions very carefully.

Leukeran can increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

What is oxaliplatin?

Oxaliplatin is a cytotoxic chemotherapy drug used to treat cancer. It is a type of platinum drug and an alkylating agent.

Like other alkylating agents, oxaliplatin works by interfering with the development of DNA in a cell. It stops cells from growing and multiplying and kills them. This helps to treat cancer which is caused by cells rapidly growing and dividing out of control.

Oxaliplatin was first approved by the US Food and Drug Administration (FDA) in 2002.

What is oxaliplatin used for?

Oxaliplatin is an anti-cancer (chemotherapy) medicine that is used with other anti-cancer medicines called fluorouracil and leucovorin to treat people with:

• stage III colon cancer after surgery to remove the tumor
• advanced colon or rectal cancer (colorectal cancer)

It is not known if oxaliplatin is effective in children.

Important information

Oxaliplatin can cause serious allergic reactions, including allergic reactions that can lead to death.

Oxaliplatin is a platinum-based medicine. Serious allergic reactions including death can happen in people who take oxaliplatin and who have had previous allergic reactions to platinum-based medicines. Serious allergic reactions can happen within a few minutes of your oxaliplatin infusion or any time during your treatment with oxaliplatin.

Get emergency help right away if you:

• have trouble breathing
• feel like your throat is closing up

Call your doctor right away if you have any of the following signs or symptoms of an allergic reaction:

• rash
• flushed face
• hives
• itching
• swelling of your lips or tongue
• sudden cough
• dizziness or feel faint
• sweating
• chest pain

See “What are the side effects of oxaliplatin?” for information about other serious side effects.

Who should not receive oxaliplatin?

Do not receive oxaliplatin if you are allergic to any of the ingredients in oxaliplatin or other medicines that contain platinum. See the end of this leaflet for a complete list of the ingredients oxaliplatin.

Ask your doctor if you are not sure if you take a medicine that contains platinum.

What should I tell my doctor before receiving oxaliplatin?

Before receiving oxaliplatin, tell your doctor about all of your medical conditions, including if you:

• have an infection
• have lung, liver, or kidney problems
• have bleeding problems
• have or had heart problems such as an abnormal heart test called an electrocardiogram (ECG or EKG), a condition called long QT syndrome, an irregular or slow heartbeat, or a family history of heart problems.
• have had changes in the level of certain blood salt (electrolytes) level, including potassium, magnesium, and calcium
• Oxaliplatin may cause fertility problems in males and females. Talk to your doctor if this is a concern for you.

How should I receive oxaliplatin?

• Oxaliplatin is given to you into your vein through an intravenous (IV) tube.
• Your doctor will prescribe oxaliplatin in a dose that is right for you.
• Your doctor may change how often you receive oxaliplatin, your dose, or how long your infusion will take.
• You and your doctor will decide how many oxaliplatin treatments you will receive.
• It is very important that you do exactly what your doctor and nurse tell you to do.
• Some medicines may be given to you before oxaliplatin to help prevent nausea and vomiting.
• Each treatment course is given to you over 2 days. You will receive oxaliplatin on the first day only.
• There are usually 14 days between each chemotherapy treatment course.

Treatment Day 1:

• Oxaliplatin and leucovorin will be given through a thin plastic tube into a vein (intravenous infusion or IV) and given for 2 hours. You will be watched by a healthcare provider during this time.
• Right after the oxaliplatin and leucovorin are given, 2 doses of fluorouracil will be given. The first dose is given right away into your intravenous tube. The second dose will be given into your intravenous tube over the next 22 hours, using a pump device.

Treatment Day 2:

• You will not get oxaliplatin on Day 2. Leucovorin and fluorouracil will be given the same way as on Day 1.
• The fluorouracil will be given through your intravenous with a pump. If you have any problems with the pump or the tube, call your doctor, your nurse, or the person who is responsible for your pump. Do not let anyone other than a healthcare provider touch your infusion pump or tubing.

What happens if I miss a dose?

It is important for you to keep all of your medical appointments. Call your doctor if you miss an appointment. There may be special instructions for you.

What should I avoid while receiving oxaliplatin?

• Avoid cold temperatures and cold objects. Cover your skin if you go outdoors in cold temperatures.
• Do not drink cold drinks or use ice cubes in drinks.
• Do not put ice or ice packs on your body.
• Oxaliplatin can cause dizziness, vision problems, or vision loss that can affect your ability to drive or use machines. You should not drive or operate machinery if you develop these symptoms while receiving oxaliplatin.

See “How can I reduce the side effects caused by cold temperatures?” for more information.

Talk with your doctor and nurse about your level of activity during treatment with oxaliplatin. Follow their instructions.

Dosing information

• Administer oxaliplatin 85 mg/m² as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle. Administer fluorouracil and leucovorin on Day 2 as recommended.
• Adjuvant Treatment: Continue treatment for up to 12 cycles or unacceptable toxicity.
• Advanced Colorectal Cancer: Continue treatment until disease progression or unacceptable toxicity.
• See the full prescribing information for further info about dosing.

What are the side effects of oxaliplatin?

Oxaliplatin can cause serious side effects, including:

• See “Important information” above
• Nerve problems .Oxaliplatin can affect how your nerves work and make you feel. Nerve problems may happen with the first treatment or within two days after your treatment of oxaliplatin. Nerve problems may last a short time (acute) or may become persistent. Symptoms may improve after stopping treatment with oxaliplatin. Exposure to cold or cold objects may cause or worsen nerve problems. Tell your doctor right away if you get any signs of nerve problems, including:
  • very sensitive to cold temperatures and cold objects
  • trouble breathing, swallowing, or saying words, jaw tightness, odd feelings in your tongue, or chest pressure
  • pain, tingling, burning (pins and needles, numb feeling) in your hands, feet, or around your mouth or throat, which may cause problems walking, fall, or performing activities of daily living.
    
    For information on ways to lessen or help with the nerve problems, see the end of this leaflet, “How can I reduce the side effects caused by cold temperatures?”
• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain. Tell your doctor right away if you have any of the following signs and symptoms of PRES:
  • headache
  • confusion or a change in the way you think
  • seizures
  • vision problems, such as blurriness or vision loss
• Low blood cell counts (myelosuppression). Oxaliplatin when used with fluorouracil and leucovorin can cause low blood cells counts. Low blood cell counts are common with oxaliplatin when used with fluorouracil and leucovorin and can lead to serious infection and death. Tell your doctor right away if you have a fever greater than 100.9°F (38.3°C) or a prolonged fever greater than 100.4°F (38°C) for more than one hour (febrile neutropenia). Call your doctor right away if you get any of the following signs of infection:
  • chills or shivering
  • burning or pain on urination
  • pain on swallowing
  • redness or swelling at intravenous site
  • sore throat
  • persistent diarrhea
  • cough that brings up mucus
• Risk of new cancers. Leukemia, a form of blood cancer, has been reported in patients after taking oxaliplatin in combination with certain other medicines. Talk to your doctor about the potential for increased risk of this type of cancer when taking oxaliplatin and certain other medicines.
• Lung problems. Oxaliplatin can cause lung problems that may lead to death. Tell your doctor right away if you get any of the following symptoms as these may be indicators of a serious lung disease:
  • shortness of breath
  • cough
  • wheezing
• Liver problems (hepatotoxicity).Your doctor will do blood tests to check your liver when you start receiving oxaliplatin, and before each treatment course as needed.
• Heart problems. Oxaliplatin can cause heart problems that have led to death. Your doctor may do blood and heart tests during treatment with oxaliplatin if you have certain heart problems. If you faint (lose consciousness) or have an irregular heartbeat or chest pain during treatment with oxaliplatin, get medical help right away as this may be a sign of a serious heart condition.
• Muscle problems. Oxaliplatin can cause muscle damage (rhabdomyolysis) which can lead to death. Tell your doctor right away if you have muscle pain and swelling, along with weakness, fever, or red-brown urine.
• Harm to an unborn baby. See “Pregnancy and breastfeeding” below.
• Bleeding problems (hemorrhage). Oxaliplatin when used with fluorouracil and leucovorin can cause bleeding problems (hemorrhage) that can lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
  • blood in your stools or black stools (looks like tar)
  • pink or brown urine
  • unexpected bleeding, or bleeding that is severe or you cannot control
  • vomit blood or vomit that looks like coffee grounds
  • cough up blood or blood clots
  • increased bruising
  • dizziness
  • weakness
  • confusion
  • changes in speech
  • headache that lasts a long time

The most common side effects of oxaliplatin include:

• numbness, pain, tingling, and/or burning along the nerves
• low white blood cells (blood cells important for fighting infection)
• low platelet count (important for clotting and to control bleeding)
• low red blood cells (blood cells that carry oxygen to the tissues)
• nausea
• changes in liver function tests
• diarrhea
• vomiting
• tiredness
• mouth sores

Tell your doctor if you have any side effect that bothers your or that does not go away. These are not all the possible side effects of oxaliplatin. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How can I reduce the side effects caused by cold temperatures?

• Cover yourself with a blanket while you are getting your oxaliplatin infusion.
• Do not breathe deeply when exposed to cold air.
• Wear warm clothing in cold weather at all times. Cover your mouth and nose with a scarf or a pull-down cap (ski cap) to warm the air that goes to your lungs.
• Wear gloves when taking things from the freezer or refrigerator.
• Drink fluids warm or at room temperature.
• Always drink through a straw.
• Do not use ice chips if you have nausea or mouth sores. Ask your doctor about what you can use.
• Be aware that most metals are cold to touch, especially in the winter. These include your car door and mailbox. Wear gloves to touch cold objects.
• Do not run the air-conditioning at high levels in the house or in the car in hot weather.
• If your body gets cold, warm-up the affected part. If your hands get cold, wash them with warm water.
• Always let your doctor know before your next treatment how well you did since your last visit.
• Your doctor may have other useful tips for helping you with side effects.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Pregnancy and Breastfeeding

Tell your doctor if:

• you are pregnant or plan to become pregnant. Oxaliplatin may harm your unborn baby. Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with oxaliplatin.
• you are able to become pregnant, your doctor may do a pregnancy test before you start treatment with oxaliplatin and for 9 months after the final dose. Talk to your doctor about forms of birth control that may be right for you.
• you are breastfeeding or plan to breastfeed. It is not known if oxaliplatin passes into your breast milk. Do not breastfeed during treatment with oxaliplatin and for 3 months after the final dose.

Females who are able to become pregnant should avoid becoming pregnant and should use effective birth control during treatment with oxaliplatin and for 9 months after the final dose. Talk to your doctor about forms of birth control that may be right for you.

Males with female partners who are pregnant or able to become pregnant should use effective birth control during treatment with oxaliplatin and for 6 months after the final dose.

Oxaliplatin may cause fertility problems in males and females. Talk to your doctor