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Clinical Safety

Treatment readiness, biological monitoring, overlapping toxicities, emergency actions, contrast reactions and CTCAE documentation.

v0.3.1
Recommendation ≠ readinessA treatment option is not ready to give until its safety prerequisites and monitoring are resolved.
Recognize → grade → document → actRare toxicities and emergencies stay within reach, with source-linked actions.
Unknown ≠ normalMissing renal, marrow, pharmacogenetic or other safety data must remain visibly unresolved.
Clinical safety preview. Professional decision support only. Confirm current product information, validated regimen rules and local emergency procedures before acting. Adult contrast doses shown below are source-linked to the current ACR adult reaction card and are not pediatric instructions.

Regimen safety check

Select one or more agents to reveal prerequisites, follow-up and overlapping toxicity domains. Only listed, selected agents are covered. Unlisted agents and trial regimens are not assessed; review their protocol separately. No patient data are stored.

Select treatment components to reveal prerequisites, monitoring and combined toxicity signals.

Fluoropyrimidine

5-Fluorouracil (5-FU)

Safety gates

DPD / DPYD status before first exposure

Current FDA labeling recommends DPYD testing before fluorouracil unless treatment is immediately necessary. Complete DPD deficiency is a major safety contraindication.

France: uracilemia result must be considered

In France, uracilemia testing before the first prescription has been mandatory since 2019; the prescription workflow must document that the result was considered. Interpret uracilemia cautiously in moderate/severe renal impairment.

Monitoring schedule
CBCBefore each treatment cycle; weekly for weekly/similar schedules; additional checks as clinically indicated.Severe myelosuppression; typical neutrophil nadir 9–14 days after administration.
Clinical GI/mucosal reviewAt each treatment contact and urgently for early severe diarrhea/mucositis.Early unusually severe toxicity can signal DPD deficiency.
Cardiac symptomsDuring therapy; urgent assessment for chest pain, ischemic symptoms or arrhythmia.Fluoropyrimidine cardiotoxicity can be acute.
Emergency actions
Early unusually severe fluoropyrimidine toxicity
  1. Withhold 5-FU immediately.
  2. Assess for severe mucositis, diarrhea, cytopenia, neurotoxicity and DPD deficiency.
  3. Escalate according to local fluoropyrimidine-toxicity protocol.
Hyperammonemic encephalopathy
  1. Withhold 5-FU.
  2. Urgently assess mental status and serum ammonia.
  3. Initiate ammonia-lowering/supportive treatment per emergency protocol.
Fluoropyrimidine

Capecitabine

Safety gates

DPD / DPYD status before first exposure

Current FDA labeling recommends DPYD testing before capecitabine unless treatment is immediately necessary.

France: uracilemia result must be considered

French prescribing/dispensing rules require uracilemia before first fluoropyrimidine prescription and documentation that the result was considered.

Renal function and hydration

Assess renal function before treatment; renal impairment changes exposure/dose suitability.

Monitoring schedule
CBCBaseline and before each cycle.Myelosuppression can require treatment interruption or dose modification.
Renal function / hydrationBaseline and as clinically indicated; repeat promptly with dehydration/diarrhea.Renal dysfunction increases toxicity and may require dose adjustment.
GI / hand-foot symptomsAt each contact and during oral-treatment check-ins.Early recognition allows prompt interruption before severe toxicity.
Emergency actions
Early unusually severe fluoropyrimidine toxicity
  1. Withhold capecitabine.
  2. Assess DPD-related toxicity, dehydration, renal function and blood counts.
  3. Escalate urgently for severe diarrhea, mucositis, cytopenia, neurotoxicity or cardiac symptoms.
Platinum

Cisplatin

Safety gates

Renal eligibility must be verified

Document serum creatinine/renal function and the regimen-specific creatinine-clearance eligibility threshold. Do not apply one universal cutoff across all protocols.

Hydration and electrolyte plan

Ensure protocol-appropriate hydration; magnesium and other electrolytes require active surveillance.

Monitoring schedule
Creatinine, BUN, creatinine clearance, Mg/Na/K/CaBefore treatment and before subsequent courses / as required by the active regimen.Cumulative nephrotoxicity and electrolyte wasting.
Neurologic examinationBaseline and at appropriate intervals during treatment.Cumulative peripheral neuropathy may be irreversible.
Hearing assessmentBaseline and during therapy when clinically/regimen indicated.Ototoxicity can be cumulative.
Emergency actions
Severe hypersensitivity / anaphylaxis
  1. Stop cisplatin immediately.
  2. Activate local anaphylaxis/resuscitation protocol.
  3. Do not rechallenge until specialist review.
Acute severe renal/electrolyte toxicity
  1. Withhold treatment.
  2. Urgently correct clinically significant electrolyte abnormalities and assess renal injury/volume status.
  3. Escalate according to severity and local protocol.
Platinum

Carboplatin

Safety gates

Renal function is part of dose calculation

Document the renal-function method used for AUC/formula dosing; impaired renal function increases myelosuppression risk.

Prior platinum exposure / cycle count

Hypersensitivity risk rises with prior platinum exposure and later cycles; emergency medication/equipment must be available.

Monitoring schedule
CBCBefore each cycle; weekly during treatment where the active label/regimen uses weekly surveillance, and as clinically indicated.Dose-limiting thrombocytopenia/neutropenia; nadir may be delayed.
Renal functionBefore dose calculation and when renal function may have changed.Carboplatin exposure and hematologic toxicity depend on renal clearance.
Emergency actions
Acute hypersensitivity / anaphylaxis
  1. Stop carboplatin immediately.
  2. Activate local anaphylaxis/resuscitation protocol.
  3. Document platinum allergy and obtain specialist review before any future platinum exposure.
Taxane

Paclitaxel

Safety gates

Formulation-specific premedication / hypersensitivity precautions

Use the exact product/regimen protocol: solvent-based paclitaxel and albumin-bound paclitaxel are not interchangeable for premedication or dosing.

Baseline neuropathy and marrow reserve

Document neuropathy and blood counts before treatment; cumulative neuropathy may require modification.

Monitoring schedule
CBCBefore scheduled doses; frequency follows the product/regimen schedule.Dose-limiting neutropenia.
Peripheral neuropathyBaseline and before each cycle/dose series.Cumulative neurotoxicity can become functionally limiting.
Infusion reaction observationDuring administration, especially early infusions.Potential severe hypersensitivity.
Emergency actions
Severe infusion reaction
  1. Stop infusion immediately.
  2. Activate local hypersensitivity/anaphylaxis protocol.
  3. Further taxane management requires specialist review.
Extravasation
  1. Stop infusion and aspirate without flushing.
  2. Follow agent/formulation-specific extravasation pathway; current ONS/ASCO guidance supports hyaluronidase for paclitaxel/docetaxel extravasation.
  3. Use the locally specified compress strategy and follow-up.
Anti-VEGF

Bevacizumab

Safety gates

Recent/planned major surgery and wound healing

Surgical timing and wound healing must be checked against the active bevacizumab label/protocol before treatment.

Blood pressure and urine protein baseline

Do not start the monitoring pathway without baseline blood pressure and renal/proteinuria context.

Monitoring schedule
Blood pressureEvery 2–3 weeks during treatment; continue regular follow-up if treatment-induced hypertension occurs.Severe hypertension can require withholding treatment.
Urine proteinSerial dipstick urinalysis during therapy; escalate quantification when dipstick is significantly positive according to label/protocol.Proteinuria/nephrotic syndrome can require treatment interruption/discontinuation.
Bleeding/thrombotic/wound symptomsAt every treatment contact and perioperative review.Anti-VEGF vascular toxicity may become urgent.
Emergency actions
GI perforation / fistula suspicion
  1. Stop bevacizumab.
  2. Urgent surgical/acute-care assessment.
  3. Manage sepsis/peritonitis according to emergency protocol.
Major hemorrhage or hypertensive crisis
  1. Stop treatment.
  2. Activate appropriate emergency pathway.
  3. Do not resume without specialist reassessment and label/protocol review.
PD-1 inhibitor

Pembrolizumab

Safety gates

Baseline immune-toxicity laboratory context

Establish liver enzymes, creatinine and thyroid function before treatment and recognize relevant pre-existing autoimmune/endocrine conditions.

Monitoring schedule
Liver enzymes, creatinine, thyroid functionBaseline and periodically during treatment.Immune-mediated hepatitis, nephritis and endocrinopathies can initially be laboratory abnormalities.
Immune symptom screenEvery treatment contact and between cycles when new symptoms occur.Pneumonitis, colitis, hepatitis, endocrinopathy and other immune toxicities may progress rapidly.
Emergency actions
Severe suspected immune-mediated toxicity
  1. Hold pembrolizumab while severity and alternative causes are assessed.
  2. Activate the organ-specific immune-toxicity pathway; severe cases may require urgent admission and immunosuppression per guideline/label.
  3. Do not treat a potentially serious immune toxicity as routine chemotherapy nausea/diarrhea/dyspnea.
Severe infusion reaction
  1. Stop infusion.
  2. Activate local hypersensitivity/anaphylaxis protocol.
  3. Future dosing depends on reaction severity and label guidance.
DNA-binding vesicant / antitumour antibiotic

Mitomycin C (IV)

Safety gates

Vesicant administration precautions

Use reliable venous access and continuous site vigilance. Extravasation can cause delayed extensive necrosis.

Marrow and renal reserve

Document blood counts and renal function before treatment; toxicity is cumulative.

Monitoring schedule
CBC / platelets / differential / hemoglobinRepeatedly during therapy and for at least 8 weeks after therapy according to current IV mitomycin labeling; reassess before additional doses.Delayed cumulative marrow suppression can be severe.
Renal function + HUS/TMA vigilanceBaseline, before subsequent treatment, and urgently if anemia/thrombocytopenia/renal dysfunction suggest HUS/TMA.Mitomycin-associated HUS/TMA can cause irreversible renal failure.
IV siteContinuously during administration and during subsequent follow-up if symptoms arise.Tissue necrosis can evolve after extravasation.
Emergency actions
Mitomycin extravasation
  1. STOP infusion immediately. Leave the access in place initially to attempt gentle aspiration; DO NOT flush.
  2. Elevate a peripheral limb when applicable; mark/measure and photograph the area.
  3. Use a cold compress strategy and apply DMSO according to the current local/agent-specific protocol where available.
  4. Arrange early surgical/plastic-surgery escalation for high-risk, extensive, central-line, progressive or necrotic injury; continue structured follow-up because necrosis may be delayed.
Suspected HUS / thrombotic microangiopathy
  1. Stop mitomycin and do not give another dose pending evaluation.
  2. Urgently assess CBC/platelets, hemolysis markers and renal function.
  3. Escalate to acute hematology/nephrology care.