Imatinib Mesylate and Varizig

• Generic Name: imatinib
• Dosage Forms: n.a.
• Other Brand Names: Gleevec

First-line treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) CML in adult and pediatric patients who are in the chronic phase of the disease (designated an orphan drug by FDA for this use); follow-up is limited.

Second-line treatment of Ph+ CML in adults who are in blast crisis, in the accelerated phase, or in the chronic phase of the disease after failure of interferon alfa therapy (designated an orphan drug by FDA for this use).

Second-line treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplantation or who are resistant to interferon alfa therapy.

Efficacy in pediatric patients determined based on overall hematologic and/or cytogenetic response rates; actual clinical benefits (e.g., decrease in disease-related symptoms, increase in survival) not adequately studied.

Treatment of relapsed or refractory Ph+ ALL in adults (designated an orphan drug by FDA for this use).

Treatment of MDS or MPD associated with gene rearrangements of platelet-derived growth factor receptor (PDGFR) in adults (designated an orphan drug by FDA for this use).

Treatment of aggressive systemic mastocytosis (ASM) in adults who lack the D816V c-Kit mutation or in whom c-Kit mutational status is unknown (designated an orphan drug by FDA for this use).

Ineffective for ASM with the D816V c-Kit mutation; other therapy is indicated.

Has not been shown to be effective in patients with less aggressive forms of SM. Therefore, not recommended for use in patients with cutaneous mastocytosis, indolent SM (smoldering SM or isolated bone marrow mastocytosis), SM with an associated clonal hematologic non-mast cell lineage disease, mast cell leukemia, mast cell sarcoma, or extracutaneous mastocytoma.

Treatment of HES and/or CEL in adults who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion), patients who are negative for FIP1L1-PDGFRα fusion kinase, or patients in whom expression of FIP1L1-PDGFRα fusion kinase is unknown (designated an orphan drug by FDA for this use).

Treatment of unresectable, recurrent, and/or metastatic DFSP in adults (designated an orphan drug by FDA for this use).

Treatment of patients with Kit (CD117)-positive unresectable and/or metastatic malignant GIST (designated an orphan drug by FDA for this use).

Efficacy determined based on objective response rates; actual clinical benefits (e.g., decrease in disease-related symptoms, increase in survival) not adequately studied.

• Generic Name: varicella zoster immune globulin
• Dosage Forms: injection, solution
• Other Brand Names: Varizig

Varicella zoster (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Chickenpox is usually mild, but it can be serious or even fatal in young infants, in adults, and in people who have a weak immune system. It can lead to severe skin infection, breathing problems, brain damage, or death.

When varicella zoster virus becomes active again in an adult, it can cause herpes zoster (also called shingles) which causes painful blisters, skin infections, severe nerve pain, and hearing or vision problems that can last for months or years.

Chickenpox is spread from person to person through the air, or by coming into contact with the fluid from a chickenpox blister.

Varizig is used in adults, children, and babies (including newborn or premature infants) who could become severely ill from exposure to varicella zoster virus. Varizig is also for use in pregnant women.

Varizig is used after exposure in people who have already come into contact with varicella virus. This medicine can help keep symptoms of the virus from becoming severe or life-threatening.

This medicine will not treat an active infection that has already developed in the body.

Varizig may also be used for purposes not listed in this medication guide.