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CALQUENCE in Combination with Obinutuzumab: For patients with previously untreated CLL, the recommended dose of CALQUENCE is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. Start CALQUENCE at Cycle 1 (each cycle is 28 days). Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing. Administer CALQUENCE prior to obinutuzumab when given on the same day.
Advise patients to swallow capsule whole with water. Advise patients not to open, break or chew the capsules. CALQUENCE may be taken with or without food. If a dose of CALQUENCE is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time. Extra capsules of CALQUENCE should not be taken to make up for a missed dose.
Recommended Dosage for Hepatic Impairment: Avoid administration of CALQUENCE in patients with severe hepatic impairment.
Dose modifications are not required for patients with mild or moderate hepatic impairment [see Pharmacology: Pharmacokinetics: Specific Populations: Hepatic Impairment under Actions; Hepatic Impairment under Precautions].
Recommended Dosage for Drug Interactions: Dose Modifications for Use with CYP3A Inhibitors or Inducers: These are described in Table 4 [see Interactions]. (See Table 4.)
Click on icon to see table/diagram/imageConcomitant Use with Gastric Acid Reducing Agents: Proton Pump Inhibitors: Avoid concomitant use [see Interactions].
H2-Receptor Antagonists: Take CALQUENCE 2 hours before taking a H2-receptor antagonist [see Interactions].
Antacids: Separate dosing by at least 2 hours [see Interactions].
Dose Modifications for Adverse Reactions: Recommended dose modifications of CALQUENCE for Grade 3 or greater adverse reactions are provided in Table 5. (See Table 5.)
Click on icon to see table/diagram/imageRefer to the obinutuzumab prescribing information for management of obinutuzumab toxicities.
