Hyperglycemia 

Pre-dose fasting blood glucose 

160 mg/dL or more or random/non-fasting blood glucose of 200 mg/dL or more 

 

Withhold ALIQOPA until fasting glucose is 160 mg/dL or less, or a random/non-fasting blood glucose of 200 mg/dL or less.

 

Pre-dose or post-dose blood glucose 500 mg/dL or more 

 

On first occurrence, withhold ALIQOPA until fasting blood glucose is 160 mg/dL or less, or a random/non-fasting blood glucose of 200 mg/dL or less. Then reduce ALIQOPA from 60 mg to 45 mg and maintain.

On subsequent occurrences, withhold ALIQOPA until fasting blood glucose is 160 mg/dL or less, or a random/non-fasting blood glucose of 200 mg/dL or less. Then reduce ALIQOPA from 45 mg to 30 mg and maintain. If persistent at 30 mg, discontinue ALIQOPA.

Hypertension 

Pre-dose blood pressure (BP) 150/90 or greaterc 

 

Withhold ALIQOPA until BP is less than 150/90 based on two consecutive BP measurements at least 15 minutes apart. 

 

Post-dose BP 150/90 or greaterc (non-life-threatening):  

 

If anti-hypertensive treatment is not required, continue ALIQOPA at previous dose. If anti-hypertensive treatment is required, consider reduction of ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg. Discontinue ALIQOPA if BP remains uncontrolled (BP greater than 150/90) despite anti-hypertensive treatment [see Warnings and Precautions (5.3)]. 

 

Post-dose elevated BP with life-threatening consequences 

 

Discontinue ALIQOPA.

Non-infectious pneumonitis (NIP) 

Grade 2 

 

Withhold ALIQOPA and treat NIP. If NIP recovers to Grade 0 or 1, resume ALIQOPA at 45 mg. 

 

If Grade 2 NIP recurs, discontinue ALIQOPA.

 

 

Grade 3 or higher 

 

Discontinue ALIQOPA.

 

Neutropenia 

 

Absolute neutrophil count (ANC) 0.5 to 1.0 x 103 cells/mm3 

 

Maintain ALIQOPA dose. Monitor ANC at least weekly.

 

ANC less than 0.5 x 103 cells/mm3 

 

Withhold ALIQOPA. Monitor ANC at least weekly until ANC 0.5 x 103 cells/mm3 or greater, then resume ALIQOPA at previous dose. If ANC 0.5 x 103 cells/mm3 or less recurs, then reduce ALIQOPA to 45 mg.

Severe cutaneous reactions 

Grade 3 

 

Withhold ALIQOPA until toxicity is resolved and reduce ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg.

 

Life-threatening 

 

Discontinue ALIQOPA.

 

Thrombocytopenia 

 

Less than 25 x 109/L  

 

Withhold ALIQOPA; resume when platelet levels return to 75.0 x 109/L or greater. If recovery occurs within 21 days, reduce ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg. If recovery does not occur within 21 days, discontinue ALIQOPA.

 

Other severe and non-life-threatening toxicities 

 

Grade 3 

 

Withhold ALIQOPA until toxicity is resolved and reduce ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg.

 

 

aEnsure a minimum of 7 days between any two consecutive infusions.