How to access Krazati from Saudi Arabia, the named-patient import pathway, 2026

By Reserve Meds, Clinical and regulatory team. Last reviewed 2026-05-13.

A Saudi patient with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRAS G12C mutation, after at least one prior systemic therapy, or with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (in combination with cetuximab), may receive a prescription for Krazati (adagrasib) from their treating oncologist. Krazati is FDA-approved in the United States and now manufactured by Bristol Myers Squibb following the BMS acquisition of Mirati Therapeutics. It is a small-molecule KRAS G12C covalent inhibitor administered orally. Local availability of Krazati in the Kingdom of Saudi Arabia can be inconsistent: the drug may not be on every oncology pharmacy's standing formulary, the specific indication may not match what is locally registered, or the strength required may be back-ordered. When that happens, a named-patient import pathway through the Saudi Food and Drug Authority (SFDA) remains a legitimate route for the patient whose physician has already prescribed the drug.

This guide explains the pathway, the documentation your physician needs, typical costs and indicative timing, and where Reserve Meds fits in.

The clinical situation

Krazati covalently binds the cysteine at position 12 of the mutant KRAS G12C protein, locking it in the inactive GDP-bound state. Standard adult dosing is 600 mg orally twice daily. Confirmation of a KRAS G12C mutation by an FDA-approved companion diagnostic, or an equivalent locally accredited next-generation sequencing test, is required before initiation. Baseline workup per FDA labeling includes complete blood count, hepatic function, renal function, electrolytes (magnesium, potassium), ECG (QTc prolongation is a known signal, especially with concomitant QT-prolonging agents or CYP3A inhibitors), and pregnancy testing where applicable. Important warnings include gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, interstitial lung disease and pneumonitis, and embryo-fetal toxicity. Your oncologist will discuss the risk-benefit profile and schedule monitoring before initiating therapy.

Is Krazati legally importable into Saudi Arabia?

Yes, through the Saudi Food and Drug Authority (SFDA) named-patient and personal-use import framework, coordinated with the treating facility's pharmacy. The Kingdom has an established pathway for specialty oncology medicines approved by reference authorities (US FDA, EMA, MHRA) but not stocked or registered for the specific indication locally.

The SFDA named-patient route allows a Saudi-licensed physician to request import of a medicine when: (a) the medicine is approved by a recognised reference authority, (b) no clinically equivalent locally registered alternative is suitable for the patient's indication and history, (c) the treating physician takes clinical responsibility for use, and (d) chain of custody is documented from the US source to the administering facility.

How the pathway works, step by step

  1. Consultation with your treating oncologist. The prescribing decision is clinical. Your oncologist documents the indication, KRAS G12C mutation status (NGS or companion diagnostic report), prior therapies, and rationale for Krazati.
  2. Baseline screening. CBC, LFTs, renal function, electrolytes, ECG, and pregnancy testing where applicable are confirmed and documented. Concomitant medication review for CYP3A and QT-prolonging interactions is performed.
  3. SFDA named-patient application. Your oncologist or the hospital's import pharmacy files the application with clinical rationale, mutation status documentation, patient reference, product strength (200 mg tablets), quantity requested, and chain-of-custody plan.
  4. US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure product from Bristol Myers Squibb's authorised distribution under DSCSA chain-of-custody.
  5. Shipment. Krazati is an oral tablet with controlled-room-temperature storage requirements. Shipments include temperature-monitored packaging and tamper-evident seals.
  6. Arrival and first dose. The dispensing pharmacy releases product against the physician's prescription, and your oncologist initiates therapy with scheduled ECG and lab follow-up.

What documentation your physician needs

Your physician will typically need to provide:

  • A clinical rationale letter confirming diagnosis, KRAS G12C mutation status (with NGS or companion diagnostic report), prior therapy history, and Krazati as the indicated next step
  • Verification of their Saudi medical licence (SCFHS registration)
  • A patient identifier, anonymised reference where privacy is preferred
  • Documented pre-treatment screening (CBC, LFTs, renal, electrolytes, ECG) consistent with FDA labeling
  • The planned dosing strength and schedule (600 mg twice daily; with cetuximab if colorectal indication)
  • A discussion note on the QTc monitoring plan and concomitant medication review

Reserve Meds provides a physician documentation kit that bundles the templates SFDA reviewers expect to see for KRAS G12C targeted therapy.

Typical costs and indicative timing

Reserve Meds gives you a drug-only reference range plus a transparent delivered quote at intake. As an illustrative composite case, the US cash-pay reference range for a 30-day supply of Krazati (600 mg BID) sits in an indicative 2026 band of roughly USD 21,000 to 25,000. International logistics, SFDA documentation handling, shipping, and concierge coordination add incremental cost. The delivered quote we issue at intake shows each line separately.

Indicative timing for first dose after cohort intake opens is approximately 2 to 5 weeks from the moment a complete application is submitted to SFDA, assuming the documentation package and KRAS G12C report are clean on first pass. Refills ship on a rolling cadence aligned to your monthly supply.

Reserve Meds is in pre-launch. Service availability is limited to our first cohort. All timelines are indicative, not guarantees.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Krazati specifically, we provide:

  • Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody from manufacturer to export.
  • Documentation. Regulatory package tailored for your physician and for SFDA review, including QTc and CYP3A interaction monitoring templates.
  • Logistics. Temperature-monitored, internationally tracked shipment to your named dispensing facility.
  • Concierge case lead. A named point of contact for your family and your physician across the full case arc.

We are a coordinator. We are not the prescriber, not a pharmacy, and not a dispensing facility. All clinical decisions remain with your treating oncologist, and dispensing sits with the licensed Saudi pharmacy of record. Reserve Meds operates on cash-pay only and does not bill insurance.

Frequently asked

Is this legal in Saudi Arabia? Yes, when executed through the SFDA named-patient and personal-use framework with appropriate documentation, clinical rationale, and a licensed dispensing facility. The pathway is routinely used across Saudi oncology.

How does Krazati compare with Lumakras (sotorasib)? Both are KRAS G12C inhibitors. Krazati has CNS penetration data and a separate FDA-approved indication in colorectal cancer with cetuximab. Lumakras (sotorasib) is the alternative G12C inhibitor with a once-daily schedule. Your oncologist makes that determination based on your tumor type, brain metastasis status, and prior therapy.

What about the QTc warning? Krazati can prolong the QTc interval and interacts with CYP3A and other QT-prolonging drugs. Your oncologist will review concomitant medications and schedule ECG monitoring per labeling. Reserve Meds does not make that clinical judgement, your physician does.

Will my private health insurance cover this? Cash-pay is the default posture. Some Saudi private insurers and CCHI-aligned plans reimburse named-patient oncology imports on a case-by-case basis when the documentation package is strong. We supply documentation for your submission but do not process insurance claims.

What if my oncologist has not filed a named-patient request before? Named-patient import is an institutional process most major Saudi cancer centers (King Faisal Specialist Hospital and Research Centre, King Abdulaziz Medical City, KFSHRC Jeddah) have encountered. Our documentation kit is written for first-time applicants and tracks what SFDA reviewers commonly ask for.

Join the waitlist

Reserve Meds is opening to a limited first cohort in 2026. Add your case to the waitlist and our concierge case lead will reach out when we are ready to enter intake for Krazati coordination in the Kingdom of Saudi Arabia.

Add me to the Krazati waitlist

Composite case examples. Reserve Meds is in pre-launch. This content is for general information and does not constitute medical advice. Reserved for you.