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BESPONSA (INOTUZUMAB OZOGAMICIN)
- B-cell acute lymphoblastic leukemia
0.9 mg(0.25 mg/mL initial concentration) intravenous solution
- Dosage information is not available
B-cell acute lymphoblastic leukemia
- Infuse 0.8 mg/m2 over 1 hour(s) by intravenous route on day 1 of a 21-day treatment cycle (cycle 1)
- Infuse 0.5 mg/m2 over 1 hour(s) by intravenous route on days 8 and 15Of a 21 day treatment cycle (cycle 1)
- Infuse 0.5 mg/m2 over 1 hour(s) by intravenous route on days 1, 8 and15 of a 28 day treatment cycle (cycles 2 and beyond)
- Infuse 0.8 mg/m2 over 1 hour(s) by intravenous route on day 1 of a 28Day treatment cycle (cycles 2 and beyond)
- Infuse 0.5 mg/m2 over 1 hour(s) by intravenous route on days 8 and 15Of a 28 day treatment cycle (cycles 2 and beyond)
- Infuse 0.375 mg/m2 over 1 hour(s) by intravenous route on days 1, 8 and 15 of a 28 day treatment cycle (cycles 2 and beyond)
- adenovirus vac live type-4 & 7
- adenovirus vaccine live type-4
- adenovirus vaccine live type-7
- BCG vaccine, live (PF)
- flu vac,qval 2013-14 (2-49yrs)
- Flumist 2013-2014
- M-m-r Ii (pf)
- measles,mumps&rubella vacc(PF)
- measles,mumps,rub,varicel(PF)
- natalizumab
- Proquad (pf)
- Rotateq Vaccine
- rotavirus vaccine live, penta
- typhoid vaccine
- Tysabri
- varicella virus vacc live (PF)
- Varivax (pf)
- Vivotif Berna Vaccine
- yellow fever vaccine live (PF)
- Yf-vax (pf)
- Zostavax (pf)
- zoster vaccine live (PF)
Contraindicated
- clozapine
- Clozaril
- deferiprone
- Fazaclo
- Ferriprox
- Versacloz
Severe
Moderate
- None
- Congenital long QT syndrome
- Lactating mother
Contraindicated
- Abnormal hepatic function tests
- Disease of liver
- Hypocalcemia
- Hypokalemia
- Hypomagnesemia
- Neutropenic disorder
- Pregnancy
- Thrombocytopenic disorder
Severe
Moderate
- None
BESPONSA (INOTUZUMAB OZOGAMICIN)
- B-cell acute lymphoblastic leukemia
- Anemia
- Hemorrhage
- Hyperbilirubinemia
- Infection
- Leukopenia
- Neutropenic disorder
- Thrombocytopenic disorder
- Acute abdominal pain
- Fatigue
- Fever
- Headache disorder
- Nausea
More Frequent
Severe
Less Severe
- Ascites
- Chemotherapy-induced hyperuricemia
- Dyspnea
- Elevated serum amylase
- Elevated serum lipase
- Lymphopenia
- Pancytopenia
- Prolonged QT interval
- Abdominal distension
- Anorexia
- Chills
- Constipation
- Diarrhea
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Hepatic veno-occlusive disease
- Hepatitis
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Inotuzumab
No pediatric safety and efficacy established.
- 1 Day – 18 Years
- No pediatric safety and efficacy established.
Inotuzumab Ozogamicin
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
Inotuzumab Ozogamicin
Insufficient data avail; potential for serious adverse effects
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Insufficient data avail; potential for serious adverse effects |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- This drug may cause serious (possibly fatal) liver disease. The risk may be greater in older adults, people with liver disease, people with stem cell transplant (before or after treatment), people receiving certain medications to prepare for stem cell transplant, or people who receive this medication for a long period of time. Get medical help right away if you have any symptoms of liver damage, such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine, swelling abdomen, rapid weight gain.<br /><br /> In people who receive this medication and also have a stem cell transplant, there may be an increased risk of death due to other causes (such as infection, liver disease). Talk to your doctor for more details.
| B-cell acute lymphoblastic leukemia | |
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
| 0-9 | A-Z |
|---|---|
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
Formulary Reference Tool