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ICLUSIG (ponatinib HCl)
- Accelerated phase chronic myelocytic leukemia
- Blastic phase chronic myeloid leukemia
- Chronic phase chronic myeloid leukemia
- Philadelphia chromosome positive ALL
15 mg tablet
- 2 tablets (30 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
45 mg tablet
- 1 tablet (45 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
Accelerated phase chronic myelocytic leukemia
- 1 tablet (15 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 2 tablets (30 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 1 tablet (45 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
Blastic phase chronic myeloid leukemia
- 1 tablet (15 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 2 tablets (30 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 1 tablet (45 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
Chronic phase chronic myeloid leukemia
- 1 tablet (15 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 2 tablets (30 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 1 tablet (45 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
Philadelphia chromosome positive ALL
- 1 tablet (15 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 2 tablets (30 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 1 tablet (45 mg) by oral route once daily swallowing whole. Do not break, crush, dissolve and/or chew.
- 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
- B cplx-C-St.Johnwrt-K.&S.ginsg
- Belladonna-phenobarbital
- calcium-mag-B complex-D3-hrb61
- carbamazepine
- Carbatrol
- Cerebyx
- Cold & Flu Fighter
- Dilantin
- Dilantin Extended
- Dilantin Infatabs
- Dilantin Kapseal
- Dilantin-125
- Donnatal
- Epitol
- Equetro
- Fatigue Relief Complex
- fosphenytoin
- isoniazid-rifamp-pyrazinamide
- Luminal
- Lysodren
- mitotane
- Mycobutin
- Mysoline
- phenobarb-hyoscy-atropine-scop
- phenobarbital
- phenobarbital sodium
- Phenytek
- phenytoin
- phenytoin sodium
- phenytoin sodium extended
- primidone
- rifabutin
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- St. John's wort
- Tegretol
- Tegretol Xr
- vit C-St. John wort-elder-hb30
- Women's Complex
- Arterial aneurysm
- Arterial dissection
- Lactating mother
- Posterior reversible encephalopathy syndrome
Contraindicated
- Abnormal hepatic function tests
- Acute coronary arterial thrombosis
- Acute decompensated heart failure
- Acute myocardial infarction
- Anemia
- Arterial thrombosis
- Cerebral thrombosis
- Cerebrovascular accident
- Chronic heart failure
- Coronary artery disease
- Drug-induced hepatitis
- Gastrointestinal perforation
- Hemorrhage
- Hypertension
- Invasive surgical procedure
- Neutropenic disorder
- Occlusive vascular disease
- Pancreatitis
- Peripheral vascular disease
- Pregnancy
- Thrombocytopenic disorder
- Thromboembolic disorder
- Venous thrombosis
Severe
Moderate
- Bradycardia
- Edema
- Impaired wound healing
- Reactivation of hepatitis B
- Supraventricular arrhythmias
ICLUSIG (ponatinib HCl)
- Accelerated phase chronic myelocytic leukemia
- Blastic phase chronic myeloid leukemia
- Chronic phase chronic myeloid leukemia
- Philadelphia chromosome positive ALL
- Anemia
- Arterial thrombosis
- Bone marrow depression
- Hypertension
- Infection
- Leukopenia
- Lymphopenia
- Neutropenic disorder
- Pleural effusions
- Thrombocytopenic disorder
- Thrombotic disorder
- Acute abdominal pain
- Anorexia
- Arthralgias
- Constipation
- Cough
- Diarrhea
- Dry skin
- Dyspnea
- Elevated serum lipase
- Fatigue
- Fever
- Headache disorder
- Limb pain
- Myalgias
- Nausea
- Pain
- Peripheral neuropathy
- Skin rash
- Stomatitis
- Vomiting
More Frequent
Severe
Less Severe
- Acute myocardial infarction
- Atrial fibrillation
- Cerebrovascular accident
- Chronic heart failure
- Gastrointestinal hemorrhage
- Hemorrhage
- Intracerebral hemorrhage
- Pancreatitis
- Peripheral vascular disease
- Pneumonia
- Retinal hemorrhage
- Retinal vascular occlusion
- Supraventricular arrhythmias
- Supraventricular tachycardia
- Back pain
- Body fluid retention
- Bone pain
- Chills
- Dizziness
- Dry eye
- Hyperesthesia
- Hypesthesia
- Insomnia
- Macular retinal edema
- Muscle spasm
- Ocular pain
- Paresthesia
- Peripheral edema
- Weight loss
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Bradycardia
- Cataracts
- Chemotherapy-induced hyperuricemia
- Corneal ulcer
- Cranial nerve disorder
- Dehydration
- Drug-induced hepatitis
- Erythema multiforme
- Gastrointestinal perforation
- Heart block
- Hepatic failure
- Hypertensive crisis
- Impaired wound healing
- Iridocyclitis
- Iritis
- Posterior reversible encephalopathy syndrome
- Reactivation of hepatitis B
- Retinal thrombosis
- Stevens-johnson syndrome
- Thrombotic thrombocytopenic purpura
Less Severe
- Glaucoma
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Ponatinib
No safety and efficacy studies done in pediatrics.
- 1 Day – 18 Years
- No safety and efficacy studies done in pediatrics.
Ponatinib
- Severity Level:
D
- Additional Notes: Based on drug pharmacology dev tox may occur
Contraindicated
Ponatinib
Insuff human data avail; due to mechanism of action, potential for adv effect
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Insuff human data avail; due to mechanism of action, potential for adv effect |
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
Ponatinib
General-Possible increased risk of thrombocytopenia, asthenia, anorexia, increased lipase. Patients older than 65 years of age may have a reduced response to ponatinib. Cardiovascular-Increased risk of vascular occlusion (arterial and venous), heart failure, fluid retention. Monitor for dyspnea, peripheral edema. Musculoskeletal-Possible increased risk of muscle spasm.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | Y | Y | N | Y | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- Ponatinib has caused serious (sometimes fatal) blood clots (such as heart attack, stroke, pulmonary embolus-PE, deep vein thrombosis-DVT). Talk to your doctor about the risks and benefits of this medication. Get medical help right away if you develop symptoms of a blood clot, including chest/jaw/left arm pain, confusion, slurred speech, weakness on one side of the body, severe headache, severe dizziness, sudden vision changes, trouble breathing, pain/swelling/redness of arms/legs.<br /><br /> This medication can cause very serious (possibly fatal) heart failure. Tell your doctor right away if you develop symptoms of heart failure, including shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain. Ponatinib can also rarely cause very serious (possibly fatal) liver disease.<br /><br />Your doctor will order blood tests to check your liver before you start and while you are taking ponatinib. Tell your doctor right away if you develop symptoms of liver disease, including nausea/vomiting that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin. Your doctor may need to change your dosage or discontinue the drug.
| Accelerated phase chronic myelocytic leukemia | |
| C92.1 | Chronic myeloid leukemia, BCr/ABl-positive |
| C92.10 | Chronic myeloid leukemia, BCr/ABl-positive, not having achieved remission |
| C92.12 | Chronic myeloid leukemia, BCr/ABl-positive, in relapse |
| C92.2 | Atypical chronic myeloid leukemia, BCr/ABl-negative |
| C92.20 | Atypical chronic myeloid leukemia, BCr/ABl-negative, not having achieved remission |
| C92.22 | Atypical chronic myeloid leukemia, BCr/ABl-negative, in relapse |
| Blastic phase chronic myeloid leukemia | |
| C92.1 | Chronic myeloid leukemia, BCr/ABl-positive |
| C92.10 | Chronic myeloid leukemia, BCr/ABl-positive, not having achieved remission |
| C92.12 | Chronic myeloid leukemia, BCr/ABl-positive, in relapse |
| C92.2 | Atypical chronic myeloid leukemia, BCr/ABl-negative |
| C92.20 | Atypical chronic myeloid leukemia, BCr/ABl-negative, not having achieved remission |
| C92.22 | Atypical chronic myeloid leukemia, BCr/ABl-negative, in relapse |
| Chronic phase chronic myeloid leukemia | |
| C92.1 | Chronic myeloid leukemia, BCr/ABl-positive |
| C92.10 | Chronic myeloid leukemia, BCr/ABl-positive, not having achieved remission |
| C92.2 | Atypical chronic myeloid leukemia, BCr/ABl-negative |
| C92.20 | Atypical chronic myeloid leukemia, BCr/ABl-negative, not having achieved remission |
| Philadelphia chromosome positive ALL | |
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
| C91.02 | Acute lymphoblastic leukemia, in relapse |
| 0-9 | A-Z |
|---|---|
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
| C91.02 | Acute lymphoblastic leukemia, in relapse |
| C92.1 | Chronic myeloid leukemia, BCr/ABl-positive |
| C92.1 | Chronic myeloid leukemia, BCr/ABl-positive |
| C92.1 | Chronic myeloid leukemia, BCr/ABl-positive |
| C92.10 | Chronic myeloid leukemia, BCr/ABl-positive, not having achieved remission |
| C92.10 | Chronic myeloid leukemia, BCr/ABl-positive, not having achieved remission |
| C92.10 | Chronic myeloid leukemia, BCr/ABl-positive, not having achieved remission |
| C92.12 | Chronic myeloid leukemia, BCr/ABl-positive, in relapse |
| C92.12 | Chronic myeloid leukemia, BCr/ABl-positive, in relapse |
| C92.2 | Atypical chronic myeloid leukemia, BCr/ABl-negative |
| C92.2 | Atypical chronic myeloid leukemia, BCr/ABl-negative |
| C92.2 | Atypical chronic myeloid leukemia, BCr/ABl-negative |
| C92.20 | Atypical chronic myeloid leukemia, BCr/ABl-negative, not having achieved remission |
| C92.20 | Atypical chronic myeloid leukemia, BCr/ABl-negative, not having achieved remission |
| C92.20 | Atypical chronic myeloid leukemia, BCr/ABl-negative, not having achieved remission |
| C92.22 | Atypical chronic myeloid leukemia, BCr/ABl-negative, in relapse |
| C92.22 | Atypical chronic myeloid leukemia, BCr/ABl-negative, in relapse |
Formulary Reference Tool