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L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

This group comprises preparations used in the treatment of neoplastic diseases, and immunomodulating agents.
Corticosteroids for systemic use, see H02.


L04 IMMUNOSUPPRESSANTS

Immunosuppressants are defined as agents that completely or partly suppress one or more factors in the immunosystem.


L04A IMMUNOSUPPRESSANTS

This group comprises immunosuppressants excl. corticosteroids.

The DDDs are based on prophylaxis of allograft transplant rejection if this is an approved indication.


L04AA Selective immunosuppressants

Antilymphocyte immunoglobulin from horse serum is classified in L04AA03.
Antithymocyte immunoglobulin from rabbit serum is classified in L04AA04.
Oral formulations of cladribine used in multiple sclerosis are classified in this group, while parenteral formulations for cancer are classified in L01BB.

The DDD for abatacept is based on the treatment of rheumatoid arthritis.
The DDD for cladribine is based on the average calculated daily dose in the first two years (year 1 and 2) when all patients receive medication.

L04AB Tumor necrosis factor alpha (TNF-α) inhibitors

The DDDs for etanercept, infliximab and adalimumab are based on the treatment of rheumatoid arthritis.
The DDD for cerolizumab pegol is based on the treatment of Crohns Disease.

L04AC Interleukin inhibitors

Interleukin inhibitors used in asthma are classified in R03DX.
Dupilumab is classified in D11AH.

The DDDs for anakinra and tocilizumab are based on the treatment of rheumatoid arthritis.
The DDD for daclizumab is based on the treatment of multiple sclerosis.
The DDDs for ustekinumab, ixekizumab, brodalumab, and risankizumab are based on the treatment of psoriasis.

L04AD Calcineurin inhibitors
L04AE Sphingosine-1-phosphate (S1P) receptor modulators

The DDD for fingolimod is based on the treatment of multiple sclerosis.

L04AF Janus-associated kinase (JAK) inhibitors

Tyrosine kinase 2 (TYK2) inhibitors are classified in this group.

The DDD for tofacitinib is based on the treatment of rheumatoid arthritis.

L04AG Monoclonal antibodies

Monoclonal antibodies with a mechanism of action described and matching another ATC group in L04A are classified in the corresponding group e.g. L04AB - Tumor necrosis factor alpha (TNF-alpha) inhibitors, L04AC - Interleukin inhibitors or L04AJ - Complement inhibitors. All other immunosuppressant monoclonal antibodies are classified here.
Low strength products of ofatumumab used in the treatment of relapsing multiple sclerosis (RMS) are classified in this group, while high strength products for treatment of chronic lymphocytic leukaemia (CLL) are classified in L01FA.

The DDD for muromonab-CD3 is based on combination therapy in acute allograft rejection.
The DDD for efalizumab is based on the treatment of psoriasis.
The DDDs for natalizumab and alemtuzumab are based on the treatment of multiple sclerosis.
The DDD for alemtuzumab is based on the average calculated daily dose in the first two years (year 1 and 2) when all patients receive medication.

L04AH Mammalian target of rapamycin (mTOR) kinase inhibitors

Oral formulations of sirolimus used in organ transplantation are classified in this group, while parenteral and topical dermatological formulations used for neoplastic diseases are classified in L01EG.

L04AJ Complement inhibitors

The DDD for eculizumab is based on the dose given in the maintenance phase.

L04AK Dihydroorotate dehydrogenase (DHODH) inhibitors

The DDD for leflunomide is based on the treatment of rheumatoid arthritis.
The DDD for teriflunomide is based on the treatment of multiple sclerosis.

L04AX Other immunosuppressants

Oral formulations and prefilled syringe/pen of methotrexate are classified in this group. Parenteral formulations used for neoplastic diseases are classified in L01BA01.
Dimethyl fumarate indicated for multiple sclerosis or plaque psoriasis is classified here.

The DDD for thalidomide is based on the treatment of lepra.
The DDD for lenalidomide is based on the treatment of myelodysplastic syndromes.
The DDD for pomalidomide is based on the starting dose in the treatment of multiple myeloma.
The DDDs for methotrexate are based on the treatment of rheumatoid arthritis.

Last updated: 2024-01-26