INN monograph
Diphtheria / Tetanus / Pertussis / Hepatitis B vaccine
Vaccine / immunological product · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Vaccine / immunological product)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Anaphylaxis to prior dose or component.
- Live vaccines contraindicated in significant immunosuppression and usually pregnancy.
- Defer for moderate–severe acute illness.
Precautions
- Temperature of 400C within 48 hours, not due to another identifiable cause, collapse or shock-like state within 48 hours, persistent crying lasting 3 hours, occurring within 48 hours, convulsions with or without fever, occurring within 3 days.
Point of care
Dosing
Adult
0.5mL, three vaccine doses administered at intervals of at least 4 weeks.
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
N/A generally.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
N/A generally.
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Diphtheria / Tetanus / Pertussis / Hepatitis B vaccine.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [Diphtheria] Local pain, low-grade fever, myalgia.
- Serious: anaphylaxis, vaccine-specific rare events (e.g. intussusception historically with some rotavirus products). [Pertussis] Adverse reactions vary by agent.
- Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
- Report suspected ADRs via national pharmacovigilance channels. [Hepatitis B vaccine] Local pain, low-grade fever, myalgia.
- Serious: anaphylaxis, vaccine-specific rare events (e.g. intussusception historically with some rotavirus products).
Use
Indications
- active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards.
- Clinical selection for Diphtheria / Tetanus / Pertussis / Hepatitis B vaccine should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Vaccine / immunological product.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Diphtheria / Tetanus / Pertussis / Hepatitis B vaccine): MOA-ID_37 Vaccines present antigen to the adaptive immune system to generate protective antibodies and memory cells without causing full disease (or using attenuated/inactivated/subunit/mRNA platforms). Immunoglobulins provide passive temporary immunity.
ADME
Pharmacokinetics & PD
| Onset | Immune response days–weeks |
|---|---|
| Duration | Months–lifelong (schedule-dependent) |
| Route | IM / SC / ORAL / ID |
| Elimination | are product-specific. Consider food effects, protein binding, hepatic CYP/UGT |
| Half-life | when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. [Hepatitis B vaccine] Not classical PK; immunogenicity and cold-chain integrity determine effectiveness. |
Full PK/PD text
[Diphtheria] Not classical PK; immunogenicity and cold-chain integrity determine effectiveness. [Pertussis] Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. [Hepatitis B vaccine] Not classical PK; immunogenicity and cold-chain integrity determine effectiveness.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Infarix-HEPB | GlaxoSmithkline | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[Diphtheria] Inactivated vaccines (e.g. influenza, Tdap) often recommended; live vaccines generally avoided. [Pertussis] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [Hepatitis B vaccine] Inactivated vaccines (e.g. influenza, Tdap) often recommended; live vaccines generally avoided.
Lactation
[Diphtheria] Most vaccines compatible; live vaccines usually fine for breastfeeding mother. [Pertussis] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data. [Hepatitis B vaccine] Most vaccines compatible; live vaccines usually fine for breastfeeding mother.
Diet
Food & alcohol
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Vaccine / immunological product)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.