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Contract analysis / draft-medication-guide-psoriasis-rev2.docx

draft-medication-guide-psoriasis-rev2.docx

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1. Serious infections. VELONATIB is a medicine that affects your immune system. VELONATIB

1. Serious infections. VELONATIB is a medicine that affects your immune system. VELONATIB can lower the ability of your immune system to fight infections. Some people have had serious infections while taking VELONATIB, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. • You should not

2. Lymphoma and other cancers. Lymphoma and other cancers, including skin cancers, have ha

2. Lymphoma and other cancers. Lymphoma and other cancers, including skin cancers, have happened in people taking VELONATIB. Tell your healthcare provider if you have ever had any type of cancer.

3. Major adverse cardiovascular events. Major adverse cardiovascular events (sometimes cal

3. Major adverse cardiovascular events. Major adverse cardiovascular events (sometimes called MACE), including heart attack, stroke, and cardiovascular death, have happened in people taking VELONATIB. This risk may be higher in people who are current or past smokers and people who have had cardiovascular problems. • Tell your healthcare provider if you are a current or past smoker. • Tell your healthcare provider if

4. Blood clots. Blood clots in the veins of the legs (deep vein thrombosis, or DVT) or lun Standard

⚑ Commercial term

4. Blood clots. Blood clots in the veins of the legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) can happen in people taking VELONATIB. This may be life-threatening. • Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Call your healthcare provider right away or get emergency medical help if you have any of the following symptoms of a seri

1. Incorporation of CLARION-3R safety data, including any adverse reactions observed at ≥

1. Incorporation of CLARION-3R safety data, including any adverse reactions observed at ≥ 2% and greater than placebo that are not currently listed in the common side effects section;

2. Review against any intervening FDA guidance or regulatory actions affecting JAK-inhibi

2. Review against any intervening FDA guidance or regulatory actions affecting JAK-inhibitor class labeling, including any updates to the September 2021 class-wide labeling requirements;

3. Reconciliation with the updated USPI (which will itself require revision to incorporat

3. Reconciliation with the updated USPI (which will itself require revision to incorporate CLARION-3R data);

4. Re-review by Penterra Regulatory Affairs (Dr. Karen Hessler or designee) and Medical A

4. Re-review by Penterra Regulatory Affairs (Dr. Karen Hessler or designee) and Medical Affairs (Dr. Tomás Becerra or designee);

5. Updated health literacy assessment by Callendar Baines Group;

5. Updated health literacy assessment by Callendar Baines Group;

6. Confirmation from Janet Ling (VP, Quality & CMC) that no CMC changes have occurred in Medium

⚑ Confidentiality undertaking

6. Confirmation from Janet Ling (VP, Quality & CMC) that no CMC changes have occurred in the interim that would affect the ingredients section. APPENDIX: SUMMARY OF CHANGES FROM REV. 1 TO REV. 2 The following table documents each substantive revision made between Rev. 1 and Rev. 2 of this draft Medication Guide update. Reviewer Sign-Off Log CALDERWOOD & HARKNESS LLP PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT M