USE IN SPECIFIC POPULATIONS 

 

• Lactation: Advise women not to breastfeed ( 8.2). 

 

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

 

Revised: 9/2017

 

FULL PRESCRIBING INFORMATION: CONTENTS* 

 

1 INDICATIONS AND USAGE  

 

2 DOSAGE AND ADMINISTRATION  

 

2.1 Recommended Dosage  

 

2.2 Preparation and Administration  

 

2.3 Reconstitution Instructions  

 

2.4 Dilution Instructions for Intravenous Use  

 

2.5 Dose Modification for Toxicities  

 

2.6 Dose Modification for Use with Strong CYP3A Inhibitors  

 

3 DOSAGE FORMS AND STRENGTHS  

 

4 CONTRAINDICATIONS  

 

5 WARNINGS AND PRECAUTIONS  

 

5.1 Infections  

 

5.2 Hyperglycemia  

 

5.3 Hypertension  

 

5.4 Non-Infectious Pneumonitis  

 

5.5 Neutropenia  

 

5.6 Severe Cutaneous Reactions  

 

5.7 Embryo-Fetal Toxicity  

 

6 ADVERSE REACTIONS  

 

6.1 Clinical Trials Experience  

 

7 DRUG INTERACTIONS  

 

7.1 Effect of Other Drugs on Copanlisib  

 

8 USE IN SPECIFIC POPULATIONS  

 

8.1 Pregnancy  

 

8.2 Lactation  

 

8.3 Females and Males of Reproductive Potential  

 

8.4 Pediatric Use  

 

8.5 Geriatric Use  

 

11 DESCRIPTION  

 

12 CLINICAL PHARMACOLOGY  

 

12.1 Mechanism of Action  

 

12.2 Pharmacodynamics  

 

12.3 Pharmacokinetics  

 

13 NONCLINICAL TOXICOLOGY  

 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility  

 

14 CLINICAL STUDIES  

 

14.1 Relapsed Follicular Lymphoma  

 

16 HOW SUPPLIED/STORAGE AND HANDLING  

 

16.1 How Supplied  

 

16.2 Storage and Handling  

 

17 PATIENT COUNSELING INFORMATION  

* Sections or subsections omitted from the full prescribing information are not listed.  

1 INDICATIONS AND USAGE 

 

ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.