Saxsons Group
Lu-177 No-Carrier-Added + DOTATATE Theranostic Therapy Vial
n.c.a.
no carrier added
GMP
manufactured
DOTATATE
application
PRRT
indication
6.65 day
half-life

Authorised Indian Distributor

Saxsons Group

New Delhi, India · Since 1997

SX
Nuclear Medicine NM-003 AERB Importable No-Carrier-Added GMP Produced

Lu-177 n.c.a. + DOTATATE PRRT Theranostic — SSTR2+ Neuroendocrine Tumours

No-carrier-added Lutetium-177 (produced by SHINE Medical, supplied across India by Saxsons) paired with DOTATATE peptide for peptide receptor radionuclide therapy in somatostatin-receptor-positive neuroendocrine tumours. The NETTER-1 / NETTER-2 standard-of-care protocol — n.c.a. starting material, ≥99.9 % radionuclidic purity, AERB-importable, delivered cold-chain across India.

Key Features

  • No-carrier-added (n.c.a.) production for maximum specific activity
  • GMP manufacturing with Ph. Eur. radionuclidic purity ≥ 99.9%
  • Optimised for DOTATATE labelling at standard radiopharmacy conditions
  • Consistent batch-to-batch specific activity for reproducible PRRT dosimetry
  • Low Lu-177m (Lu-177 metastable) contamination — minimises long-term organ dose
View all features

All Features

  • No-carrier-added (n.c.a.) production for maximum specific activity
  • GMP manufacturing with Ph. Eur. radionuclidic purity ≥ 99.9%
  • Optimised for DOTATATE labelling at standard radiopharmacy conditions
  • Consistent batch-to-batch specific activity for reproducible PRRT dosimetry
  • Low Lu-177m (Lu-177 metastable) contamination — minimises long-term organ dose
  • Cold-chain delivery with calibration certificate for each shipment
  • Ready to label on arrival — no additional processing required
  • AERB import documentation support through Saxsons Group
  • Supported by dosimetry consultation for multi-cycle PRRT planning
  • Compatible with Lutathera (177Lu-DOTATATE) and in-house labelling protocols
  • Documentation supports regulatory filing for therapy centres
  • National delivery network for NETs programmes across India

Technical Specifications

Radionuclide Lutetium-177 (Lu-177)
Production route No-carrier-added (n.c.a.) reactor irradiation
Half-life 6.647 days
Decay emissions β⁻ (max 498 keV); γ 113 keV, 208 keV
Specific activity n.c.a. — highest batch-specific (TBq/mg)
Chemical form Lutetium(III) chloride in 0.04 M HCl
Radionuclidic purity ≥ 99.9% Lu-177 (Ph. Eur. compliant)
Lu-177m contamination < 0.001% (minimises long-term radiation burden)
Clinical indication Somatostatin receptor-positive gastroenteropancreatic NETs (SSTR2+)
Labelling target DOTATATE (177Lu-DOTATATE / Lutathera)
Standard therapy dose 7.4 GBq per cycle; 4 cycles at 8-week intervals
AERB status Import licence required; full documentation support available

Applications

PRRT — transforming neuroendocrine tumour outcomes

GEP-NET PRRT

Standard of care for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Lu-177-DOTATATE delivers β-radiation directly to SSTR2-expressing tumour cells.

Bronchopulmonary NETs

Expanding indication for SSTR2-positive pulmonary carcinoids and atypical carcinoids progressing after somatostatin analogue therapy.

Theranostic Paired Ga-68

Post-therapy Ga-68 DOTATATE PET/CT for response assessment. The same SSTR2 target enables true theranostic pairing — one imaging agent, one therapy agent.

Dosimetry-Based Planning

The 208 keV gamma from Lu-177 enables SPECT/CT dosimetry after each cycle. Personalised cycle dose adjustment based on tumour and kidney dosimetry.

Salvage & Re-treatment

Re-treatment protocols for patients relapsing after initial PRRT. n.c.a. purity ensures consistent labelling efficiency in second-line therapy.

Combination Therapy

Investigational combination with chemotherapy (CAPTEM) and targeted agents (mTOR inhibitors) in progressive NETs. n.c.a. Lu-177 is the regulatory-compliant standard.

Why Lu-177 n.c.a. + DOTATATE?

n.c.a.
Pure Lu-177

n.c.a. Lu-177 has no stable lutetium carrier, giving the highest specific activity and lowest cold-metal DOTATATE competition. This maximises tumour uptake and minimises pharmacological peptide load — critical for repeat PRRT cycles where cumulative renal dose matters.

Low Lu-177m
Kidney safety

Lu-177m (metastable) has a 160-day half-life and contributes disproportionate long-term kidney dose. Our n.c.a. production consistently achieves Lu-177m < 0.001% — the lowest contamination standard available in clinical supply.

4-cycle ready
Supply continuity

PRRT requires 4 cycles at 8-week intervals. Saxsons maintains a regular India supply schedule — your department receives Lu-177 on therapy day, calibrated to the planned activity at the time of labelling.

Catalogs & Resources

SHINE product page for the upstream Lu-177 n.c.a. starting material. Contact Saxsons for AERB import documentation, cold-chain scheduling and DOTATATE peptide kit pairing.

Available through Saxsons Group

Launch your PRRT programme in India

Contact Saxsons Group for Lu-177 + DOTATATE supply, AERB import documentation and dosimetry consultation for your neuroendocrine tumour therapy programme.