IMFINZI (Durvalumab)
IMFINZI (Durvalumab)
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IMFINZI (Durvalumab)

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What is this medication?

IMFINZI (Durvalumab)
Antineoplastic Agent, Anti-PD-L1 Monoclonal Antibody

IMFINZI (Durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody that is indicated for the treatment of locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.  Durvalumab is also indicated for unresectable, Stage III non-small cell lung cancer (NSCLC).

What are the ingredients in this medication?

Medicinal Ingredient:

Non-Medicinal Ingredients:
L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection. Preservative-free.

How does this medication work? 

IMFINZI (Durvalumab) is a human immunoglobulin G1 kappa monoclonal antibody which blocks programmed cell death ligand 1 (PD-L1) binding to PD-1 and CD80 (B7.1); PD-L1 blockade leads to increased T-cell activation, allowing T-cells to kill tumor cells.

How should I take this medication? 

Non-small cell lung cancer
IV: For patients over 30kg, 10 mg/kg is to be administered by intravenous infusion once every 2 weeks or 1,500 mg once every 4 weeks. For patients under 30kg, 10 mg/kg is to be administered by intravenous infusion once every 2 weeks.
Continue until disease progression or unacceptable toxicity or a maximum of 12 months.

Small cell lung cancer
IV: For patients over 30kg, 1,500 mg is to be administered by intravenous infusion once every 3 weeks (combined with etoposide and either carboplatin or cisplatin) for 4 cycles, followed by 1,500 mg once every 4 weeks as a single agent. For patients under 30kg, 20 mg/kg is to be administered by intravenous infusion once every 3 weeks (combined with etoposide and either carboplatin or cisplatin) for 4 cycles, followed by 10 mg/kg once every 2 weeks as a single agent.
Continue until disease progression or unacceptable toxicity.

How to Take: Infuse over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter. Do not administer other medications through the same IV line. Administer Durvalumab prior to chemotherapy (when used in combination) on the same day.

Monitor for infusion reactions. Interrupt or slow the infusion for grade 1 or 2 infusion-related reactions (consider pre-medications with subsequent infusions); discontinue permanently for grade 3 or 4 reactions.

What should I watch for while using this medication? 

Before using IMFINZI (Durvalumab), make sure your physician is aware of any allergies or medications you currently take, pre-existing medical conditions and activities you perform.  PD-1/PD-L1 blockers such as Durvalumab remove immune response inhibition, thus potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Severe and fatal immune-mediated adverse reactions may occur in any organ system or tissue. Durvalumab may cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti-PD-1/PD-L1 monoclonal antibodies. Durvalumab is associated with immune-mediated endocrinopathies such as adrenal insufficiency, diabetes mellitus, hypophysitis, and thyroid disorders. Immune-mediated colitis has occurred with Durvalumab, including grade 3 and 4 cases. Immune-mediated hepatitis has occurred with Durvalumab, including grade 3 and fatal cases. Immune-mediated nephritis with renal dysfunction has occurred (rarely), including grade 3 cases. Immune-mediated uveitis, iritis, and other ocular inflammatory toxicities may occur with Durvalumab. Some cases can be associated with retinal detachment. Immune-mediated pneumonitis has been observed (both in patients who did or did not receive prior radiation), including grade 3 and 4 and fatal cases. Pneumonitis incidence is higher in patients who have received prior thoracic radiation. Infusion reactions have been observed with Durvalumab, including severe or life-threatening infusion-related reactions. Interrupt or slow the infusion rate for mild or moderate infusion reactions.

Fatal and other serious complications may occur in patients who received allogeneic hematopoietic stem cell transplant (HSCT) before or after treatment with an anti-PD-1/PD-L1 monoclonal antibody. Use Durvalumab with caution in patients with myasthenia gravis, because of their potential to worsen or precipitate their existing condition.

What if I miss a dose?

If a dose of is missed, contact your healthcare provider as soon as possible to reschedule the appointment.

How should I store this medication?

Store in the refrigerator at 2°C to 8°C. Protect from light by storing in the original package until time of use. Do not freeze or shake.

If the prepared infusion solution is not administered immediately, it can be stored in the IV bag for up to 30 days under refrigeration at 2°C to 8°C, or for up to 12 hours at room temperature at 15°C to 30°C from the time of preparation.

What are the possible side effects of using this medication?

Peripheral edema, dermatitis, pruritus, skin rash, hyperglycemia, hyperkalemia, hypocalcemia, hyponatremia, hypothyroidism, increased gamma-glutamyl transferase, abdominal pain, colitis, constipation, decreased appetite, diarrhea, nausea, urinary tract infection, lymphocytopenia, hepatitis, infection, fatigue, musculoskeletal pain, cough, dyspnea, dyspnea on exertion, pneumonia, pneumonitis, productive cough, radiation pneumonitis, upper respiratory tract infection, fever, night sweats, dehydration, hypercalcemia, hypermagnesemia, hyperthyroidism, hypoalbuminemia, hypokalemia, dysuria, anemia, neutropenia, hyperbilirubinemia, increased serum alkaline phosphatase, severe hepatic insufficiency, increased susceptibility to infection, sepsis, voice disorder, acute renal failure, increased serum creatinine, nephritis, infusion related reaction.

Note this is not a complete list of side effects for IMFINZI (Durvalumab), only common ones.