Besponsa

Besponsa is a prescription medication used to treat a type of leukemia called B-cell acute lymphoblastic leukemia (ALL) in adults. 

Besponsa belongs to a group of drugs called monoclonal antibodies. These help by turning on the immune system to kill cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Besponsa include a change in blood cell count, infection, and fatigue. 

Besponsa is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
  

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

Serious side effects have been reported with Besponsa. See the “Besponsa Precautions” section.

Common side effects of Besponsa include the following:

• Low platelets
• Low white blood cells
• Low neutrophils
• Infections
• Fever
• Chills
• Cough
• Anemia
• Tiredness
• Nausea
• Headache
• Decline in liver function
• Abdominal pain

This is not a complete list of Besponsa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 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 take drugs that can cause an arrhythmia called Torsades des Point such as:

• certain anti-arrhythmia medications including: procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
• certain fluoroquinolone antibiotics including: levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
• certain macrolide antibiotics including: clarithromycin (Biaxin), erythromycin (EES, others)
• certain azole antifungals including: ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
• certain antidepressants including: amitriptyline, desipramine (Norpramin), imipramine (Tofranil), doxepin (Silenor), fluoxetine (Prozac, Sarafem, Symbyax), sertraline (Zoloft), venlafaxine (Effexor XR)
• certain antipsychotics including: haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
• and other medications including: cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig, arsenic trioxide (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)

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

Serious side effects have been reported with Besponsa including the following:

• infusion related reactions. Symptoms of a reaction due to the injection of Besponsa into the veins include flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, fast heart rate, itching, rash, fainting, difficulty breathing, asthma, and lowered blood pressure. If this occurs, your doctor will decide to either slow the rate at which Besponsa is injected into your veins or will stop the injection altogether.
• a decline in liver function. These symptoms include loss of appetite or start losing weight, nausea or vomiting, feel tired, stomach pain or tenderness, dark urine or light colored stools, yellowing of your skin or whites of your eyes, or fever or rash. Tell your healthcare provider about any signs or symptoms of liver damage.
• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Besponsa. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation such as feeling faint, lightheadedness, dizziness, or feeling like your heart is beating irregularly or quickly.
• lowered blood count. This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.
• low red blood cell count (anemia). Tell your doctor if you have any of these symptoms of anemia including feeling weak or tired, looking pale, or feeling short of breath
• fever. Fever is often one of the most common and earliest signs of infection. Follow your doctor's instructions about how often to take your temperature, especially during the days after treatment with Besponsa. If you have a fever, tell your doctor or nurse right away.
• stomatitis. If you experience painful redness, swelling, or sores in the mouth (symptoms of stomatitis), notify your healthcare provider right away.

Medications 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 Besponsa, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Besponsa or to any of its ingredients
• have blood or immune system problems
• have liver problems
• have heart problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. This medication may cause harm to your unborn baby. Pregnancy is not recommended during treatment with Besponsa and for at least 5 months for males and at least 8 months for females after the last dose. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Besponsa crosses into human milk. Breastfeeding is not recommended during treatment with Besponsa and for at least 2 months after the last dose.

Take Besponsa exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, notify your healthcare provider. Your dosage schedule may have to be adjusted.

The Besponsa dose you receive is based on your height and weight which is used to calculate your body surface area. It is usually injected on days 1, 8, and 15 of a cycle. These cycles are typically 21 or 28 days. Your healthcare provider will decide how many cycles you need. Follow your doctor's instructions about your individual dosing schedule. It is important to keep all of your appointments to receive your Besponsa dose. 

If side effects become intolerable, you may need to do a longer cycle length or permanently stop the medicine if potentially serious side effects occur. 

If Besponsa 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.

It is recommended to take medications before treatment with Besponsa to reduce the likelihood of having an infusion reaction. This typically includes a steroid, fever-reducing medication, and an antihistamine. Your healthcare provider will decide if this is right for you.

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME AND INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY

HEPATOTOXICITY, INCLUDING VOD

• Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received Besponsa. The risk of VOD was greater in patients who underwent HSCT after Besponsa treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. 
• Other risk factors for VOD in patients treated with Besponsa included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of Besponsa treatment cycles. 
• Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of Besponsa. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice.

INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY

• There was higher post-HSCT non-relapse mortality rate in patients receiving Besponsa, resulting in a higher Day 100 post-HSCT mortality rate.