(Source: SAHPRA-approved Patient Information Leaflet)
(Most critical safety information from the leaflet)
Immune-mediated inflammation of organs can occur and may be serious or life-threatening:
Lungs (pneumonitis)
Liver (hepatitis)
Bowel (colitis)
Hormone glands (thyroid, adrenal, pituitary, pancreas)
Kidneys (nephritis)
Heart (myocarditis)
Muscles (myositis)
Skin and mouth (severe rash, ulcers)
Early recognition is critical → treatment may need to be withheld or permanently stopped.
Severe infusion-related reactions may occur during or shortly after infusion.
Can harm an unborn baby → effective contraception required during treatment and for 3 months after last dose.
Do not breastfeed during treatment and for 3 months after last dose.
Not studied in children or adolescents (<18 years).
Patients with autoimmune disease, organ transplant, lung or liver problems require special caution.
Generic name: Durvalumab
Brand name: IMFINZI®
Drug class: Monoclonal antibody
Formulation: Concentrate for solution for IV infusion
Strengths:
120 mg / 2.4 mL vial
500 mg / 10 mL vial
Scheduling status: S4
Route: Intravenous infusion
IMFINZI® is used to treat lung cancer:
Disease has spread within the lung
Not suitable for surgery
Disease has responded or stabilised after chemotherapy and radiotherapy
Used together with chemotherapy
Disease has spread within lungs or to other parts of the body
Previously untreated disease
Administered in hospital or clinic under specialist supervision
Given as an IV infusion over ~60 minutes
10 mg/kg every 2 weeks, OR
1500 mg every 3 or 4 weeks
Dose schedule determined by treating doctor.
No fixed dose adjustments described in the leaflet
Treatment may be:
Withheld, or
Permanently discontinued
Based on severity of immune-related side effects
Used with chemotherapy in ES-SCLC
Patients must inform healthcare providers of all other medicines, including traditional or complementary medicines
Hypersensitivity to durvalumab or any excipients
Patients must urgently report symptoms of:
Pneumonitis: new/worsening cough, SOB, chest pain
Hepatitis: nausea, right-sided abdominal pain, jaundice, dark urine, bleeding/bruising
Colitis: diarrhoea, blood/mucus in stool, severe abdominal pain
Endocrinopathies: fatigue, headaches, weight changes, dizziness, mood changes, polyuria, polydipsia
Nephritis: reduced urine output, ankle swelling
Skin/mucosal reactions: rash, blistering, mouth ulcers
Cardiac inflammation: chest pain, palpitations, SOB
Myositis: muscle weakness or pain
Infusion reactions: chills, fever, rash, wheezing, dizziness, facial swelling
Cough
Diarrhoea
Stomach pain
Skin rash or itching
Fever
Peripheral oedema
Upper respiratory tract infection
Oral fungal infection
Flu-like illness
Raised blood sugar (type 1 diabetes mellitus)
Hoarse voice (dysphonia)
Colitis
Night sweats
Pneumonitis
Pneumonia
Fever with systemic symptoms
Severe immune-mediated inflammation
No specific interactions listed
All medicines must be disclosed to the treating clinician
Pregnancy: Contraindicated; effective contraception required
Breastfeeding: Contraindicated
Autoimmune disease: Use with caution
Organ transplant recipients: Use with caution
HIV: Not studied
Children/adolescents: Not recommended
Duration determined by treating doctor
Treatment may be stopped if:
Severe immune-mediated toxicity occurs
Serious infusion reactions develop
Suspected immune-mediated toxicity:
→ Urgent assessment
→ Additional medicines may be given
→ Delay or stop IMFINZI®
Infusion reactions:
→ Immediate medical management
Do not miss doses — reschedule urgently if appointment missed
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2022/09/imfinzi-pil-dated.pdf
| Trade Name | |
|---|---|
| Drug Class | 1 |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Lung Cancer |
| Dosage |