Kanjinti

Kanjinti is a prescription medication used to treat breast cancer and stomach cancer. It may be used alone or in combination with other medications. Kanjinti belongs to a group of drugs called monoclonal antibodies, which help stop the growth of cancer cells.

This medication comes in an injectable form and is given into the vein (IV) by a healthcare provider once every week or once every 3 weeks.

Common side effects of Kanjinti include fever, nausea, and vomiting.

Kanjinti is a prescription medication used alone or in combination with other medications to treat certain types of breast cancer that has spread to other parts of the body. Kanjinti is also used with other medications to treat stomach cancer that has spread to other parts of the body. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Kanjinti may cause serious side effects (see "Kanjinti Precautions").

• Some patients receiving trastuzumab products, like Kanjinti, for breast cancer had the following side effects: 
  • Fever 
  • Feeling sick to your stomach (nausea) 
  • Throwing up (vomiting) 
  • Infusion reactions 
  • Diarrhea 
  • Infections 
  • Increased cough 
  • Headache 
  • Feeling tired 
  • Shortness of breath 
  • Rash 
  • Low white and red blood cell counts 
  • Muscle pain 

• Some patients receiving trastuzumab products, like Kanjinti, for stomach cancer that had spread (metastatic) had the following side effects:
  • Low white blood cell counts
  • Diarrhea
  • Feeling tired
  • Low red blood cell counts
  • Swelling of the mouth lining
  • Weight loss
  • Upper respiratory tract infections
  • Fever
  • Low platelet counts
  • Swelling of the mucous membranes
  • Swelling of the nose and throat
  • Change in taste 

These are not all the possible side effects of Kanjinti. For more information, ask your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are being treated with:

• daunorubicin (Daunoxome, Cerubidine)
• doxorubicin (Doxil)
• epirubicin (Ellence)
• idarubicin (Idamycin)
• paclitaxel (Abraxane, Taxol)

This is not a complete list of Kanjinti drug interactions. Ask your doctor or pharmacist for more information.

Heart Problems

• Kanjinti treatment can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Kanjinti and a certain type of chemotherapy (anthracycline). One patient died in an adjuvant (early) breast cancer trial of significantly weakened heart muscle.
• Kanjinti can cause serious heart problems, including:
  • A decline in heart function
  • Irregular heartbeats
  • High blood pressure
  • Serious heart attack
  • Death
• Your doctor will stop Kanjinti therapy if you have weakening of the heart muscle or changes in the heart muscle structure.

Monitoring the Heart

• Your doctor will evaluate your heart function before and during treatment. For adjuvant breast cancer therapy, your doctor will also evaluate heart function after the end of treatment.
• Your doctor may run tests, such as an echocardiogram or a MUGA scan, and will review your health history to see how well the heart muscle is working.
• If you are taking Kanjinti and have stopped treatment temporarily because of significant heart problems, your doctor should monitor your heart health more frequently.

Infusion Reactions

• Some patients have had serious infusion reactions and lung problems; infusion reactions leading to death have been reported
• Symptoms usually happen during or within 24 hours of taking Kanjinti
• Your infusion should be temporarily stopped if you experience shortness of breath or very low blood pressure
• Your doctor should monitor you until these symptoms completely go away
• Your doctor may have you completely stop Kanjinti treatment if you have:
  • A severe allergic reaction
  • Swelling
  • Lung problems
  • Swelling of the lungs
  • Severe shortness of breath
• Infusion reaction symptoms consist of:

• Fever and chills
• Nausea
• Vomiting
• Pain (in some cases at tumor sites)
• Headache
• Dizziness
• Shortness of breath
• Very low blood pressure
• Rash
• Lack of energy and strength

Pregnancy

• Kanjinti can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman
• You should use effective birth control methods while receiving Kanjinti and for at least 6 months after you finish taking Kanjinti
• Nursing mothers taking Kanjinti may want to stop nursing or stop Kanjinti, depending on the importance of the drug to the mother

Lung Problems

Taking Kanjinti Can Result in Serious and Potentially Deadly Lung Problems, Including:

• A severe shortness of breath
• Fluid in or around the lungs
• Weakening of the valve between the heart and the lungs
• Too little oxygen in the body
• Swelling of the lungs
• Scarring of the lungs

Problems like these may occur after an infusion reaction. If you have trouble breathing at rest due to existing lung disease, or large lung tumors appear, you may have more serious lung problems. Your doctor should stop Kanjinti if you experience lung problems.

Worsening of Low White Blood Cell Counts Due to Chemotherapy

• Worsening of low white blood cell counts to serious and life-threatening levels and associated fever were higher in patients taking Kanjinti in combination with chemotherapy when compared with those who received chemotherapy alone. The likelihood that a patient will die from infection was similar among patients who received Kanjinti and those who did not

HER2 Testing

• You must have a HER2 test to determine if your cancer is HER2-positive before taking Kanjinti, as benefit has only been shown in patients whose tumors are HER2-positive

• You should contact your doctor immediately for any of the following:
  • New onset or worsening shortness of breath
  • Cough
  • Swelling of the ankles/legs
  • Swelling of the face
  • Palpitations
  • Weight gain of more than 5 pounds in 24 hours
  • Dizziness or loss of consciousness
• If you are pregnant or of childbearing potential, you should know that Kanjinti exposure can result in harm to the fetus (unborn baby)
• You should use effective birth control methods during treatment and for a minimum of six months following Kanjinti
• If you are nursing your baby, you should stop taking Kanjinti or stop nursing

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kanjinti there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Kanjinti, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are a woman who could become pregnant, or may be pregnant.
  • Kanjinti may result in the death of an unborn baby or birth defects.
  • Contraception should be used while receiving Kanjinti and for seven months after your last dose of Kanjinti. 
  • Tell your doctor right away if you are exposed to Kanjinti during pregnancy or within 7 months of becoming pregnant.

• Have any signs of SEVERE LUNG PROBLEMS, including:
  • Severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • Not enough oxygen in the body
  • Swelling of the lungs
  • Scarring of the lungs
  • Your doctor may check for signs of severe lung problems 

• Have LOW WHITE BLOOD CELL COUNTS
  • Low white blood cell counts can be life threatening. 
  • Low white blood cell counts were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.
  • Your doctor may test your blood and check for signs of low white blood cell counts.

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

Tell your healthcare provider if you are pregnant or planning to become pregnant.

• Kanjinti may result in the death of an unborn baby or birth defects.
• Contraception should be used while receiving Kanjinti and for seven months after your last dose of Kanjinti. 
• Tell your doctor right away if you are exposed to Kanjinti during pregnancy or within 7 months of becoming pregnant.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

Nursing mothers taking Kanjinti may want to stop nursing or stop trastuzumab, depending on the importance of the drug to the mother. Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known if Kanjinti is excreted in human breast milk or if it will harm your baby.

Your healthcare provider may choose to use Kanjinti with or without chemotherapy. Your healthcare provider will discuss which combination of treatments is right for you.

Kanjinti is given intravenously (IV) by a healthcare provider in a medical setting (healthcare provider's office, or hospital). The first dose is usually given over 90 minutes. Subsequent maintenance doses may be given over 30 minutes if the first dose is well-tolerated. Kanjinti is given once a week or every three weeks, depending on the chosen dosing regimen.

Your doctor will monitor the side effects you experience and your response to therapy, as well as:

• how well your heart, kidneys and liver are functioning
• your complete blood count (CBC)

Take this medication exactly as prescribed by your doctor. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

Adjuvant Treatment of HER2-Overexpressing Breast Cancer

• Option 1: Starting dose of 4 mg/kg over 90 minute IV (into the vein) infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks.
• Option 2: Starting dose of 8 mg/kg over 90 minutes IV (into the vein) infusion, then 6 mg/kg over 30–90 minutes IV infusion every three weeks for 52 weeks.

Metastatic HER2-Overexpressing Breast Cancer

• Starting dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions.

Metastatic HER2-overexpressing Gastric Cancer 

• Starting dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.

Kanjinti is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

While you are receiving Kanjinti, your doctor may require you have certain lab tests to check your body's response. Be certain to keep all appointments with your doctor and the laboratory.

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

Trastuzumab products administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with KANJINTI. Discontinue KANJINTI treatment in patients receiving adjuvant therapy and withhold KANJINTI in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration and Warnings and Precautions.

Infusion Reactions; Pulmonary Toxicity

Trastuzumab products administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue KANJINTI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions.

Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
[see Warnings and Precautions (5.3) and Use in Specific Populations.