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ADEGRAMOTIDE
Generic Name: ADEGRAMOTIDE
ABSTRACT -
Adegramotide is a synthetic peptide component of DSP-7888, an investigational therapeutic cancer vaccine also described with nelatimotide and ombipepimut-S emulsion terminology. The vaccine contains Wilms tumor 1 (WT1)-derived epitopes intended to induce WT1-specific cytotoxic and helper T-cell responses against WT1-expressing tumors. It has been studied in hematologic malignancies and solid tumors including glioblastoma and ovarian cancer, but it is not a routine approved therapy.
DOSAGE -
Adegramotide/DSP-7888 is investigational and has no universally established approved dosage regimen.
- It has been studied as a peptide vaccine emulsion administered according to protocol-defined schedules.
- Clinical trials have evaluated repeated dosing with monitoring for injection-site reactions and immune response.
- Dose, route, schedule, adjuvant/emulsion formulation, and combination therapy must follow the study protocol.
- It should not be used outside a specialist oncology or clinical-trial setting.
SIDE EFFECTS–
Reported or potential side effects may include:
- Injection-site pain, redness, swelling, or induration
- Fever
- Chills
- Fatigue
- Headache
- Nausea
- Rash or itching
- Flu-like symptoms
- Lymph node swelling
- Laboratory abnormalities
- Immune-mediated inflammation
- Allergic or hypersensitivity reactions
ALLRGIC REACTIONS–
(These symptoms may indicate an allergic reaction to the drug.)
- Skin rash
- Itching
- Hives
- Swelling of face, lips, tongue, or throat
- Difficulty breathing
- Wheezing
- Severe dizziness
- Rapid heartbeat
- Chest tightness
- Anaphylaxis
- Severe hypersensitivity reactions
DRUG INTERACTIONS–
The full drug-interaction profile has not been completely established. Use caution with:
- Immune checkpoint inhibitors or other immunotherapies
- Chemotherapy, radiotherapy, or targeted therapy with overlapping toxicity
- Systemic corticosteroids or immunosuppressants that may reduce vaccine immune response
- Other vaccines administered near the study treatment window
- Other investigational medicines or therapies used in the same protocol
- Medicines that increase the risk of overlapping organ toxicity
- Immunosuppressive, anticancer, antiviral, cardiovascular, or neurologic medicines when clinically relevant
- Herbal products and supplements with uncertain pharmacologic effects
PREAUTIONS–
- Confirm tumor WT1 expression or protocol-specific eligibility criteria when required.
- Monitor injection sites, immune-related symptoms, fever, and clinical signs of disease progression.
- Use caution in patients with autoimmune disease, transplant history, active infection, or significant immunosuppression.
- Use only in settings where qualified healthcare professionals can assess eligibility, monitor response, and manage adverse reactions.
- Review baseline medical history, organ function, concomitant medicines, pregnancy status, and allergy history before use.
- Monitor clinical symptoms and laboratory values as directed by the clinical protocol or treating specialist.
- Use caution in patients with severe hepatic, renal, cardiovascular, infectious, immune, or neurologic disease unless specifically allowed by protocol.
- Use during pregnancy or breastfeeding only if the potential benefit justifies the potential risk and as directed by a physician.
- Safety and effectiveness in pediatric patients may not be established unless specifically studied.
WARNINGS –
- Therapeutic cancer vaccines may cause injection-site reactions, systemic immune symptoms, or immune-mediated toxicity, especially with combination immunotherapy.
- This medicine is investigational or has limited publicly established clinical-use information; safety, efficacy, optimal dose, and routine clinical role may not be fully established.
- It should not be used for self-medication or substituted for an approved therapy unless directed by a qualified specialist or clinical-trial investigator.
- Treatment should be discontinued and urgent medical care sought if severe allergic reaction, severe adverse reaction, or clinical deterioration is suspected.
- Use only under medical supervision in an appropriate specialist or clinical-trial setting.
- Keep out of reach of children.
- In case of overdose or severe adverse reaction, seek immediate emergency medical attention.
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