DEPO-NISOLONE

What it is

DEPO-NISOLONE is a suspension for injection containing 40 mg of methylprednisolone acetate per mL. It is formulated for intramuscular, intra-articular, soft tissue or intralesional injection only, and is not for intravenous, intrathecal or epidural use.

Approved indications

For intramuscular administration when oral therapy is not feasible, DEPO-NISOLONE is indicated for endocrine disorders including primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, preoperative management in patients with adrenal insufficiency, congenital adrenal hyperplasia, hypercalcaemia associated with cancer, and non-suppurative thyroiditis. For rheumatic disorders, it is indicated as adjunctive therapy for short-term administration in post-traumatic osteoarthritis, epicondylitis, synovitis of osteoarthritis, acute non-specific tenosynovitis, rheumatoid arthritis including juvenile rheumatoid arthritis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, and acute and subacute bursitis. For collagen diseases, it is indicated during an exacerbation or as maintenance therapy in systemic lupus erythematosus, acute rheumatic carditis, and systemic dermatomyositis (polymyositis). For dermatological diseases, it is indicated for pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson Syndrome), severe seborrhoeic dermatitis, exfoliative dermatitis, severe psoriasis, and mycosis fungoides. For allergic states, it is indicated for control of severe or incapacitating allergic conditions intractable to conventional treatment, including bronchial asthma, drug hypersensitivity reactions, contact dermatitis, urticarial transfusion reactions, atopic dermatitis, acute non-infectious laryngeal oedema, and serum sickness. For ophthalmic diseases, it is indicated for severe acute and chronic allergic and inflammatory processes involving the eye, such as herpes zoster ophthalmicus, sympathetic ophthalmia, iritis, iridocyclitis, anterior segment inflammation, chorioretinitis, allergic conjunctivitis, diffuse posterior uveitis, allergic corneal marginal ulcers, optic neuritis, and keratitis. For gastrointestinal diseases, it is indicated to tide the patient over a critical period in ulcerative colitis (systemic therapy) and regional enteritis (systemic therapy). For respiratory diseases, it is indicated for symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy, aspiration pneumonitis, and Loeffler's Syndrome not manageable by other means. For haematological disorders, it is indicated for acquired (autoimmune) haemolytic anaemia, erythroblastopenia (RBC anaemia), secondary thrombocytopenia in adults, and congenital (erythroid) hypoplastic anaemia. For neoplastic diseases, it is indicated for palliative management of leukaemias and lymphomas in adults and acute leukaemia in childhood. For oedematous states, it is indicated to induce diuresis or remission of proteinuria in the nephrotic syndrome without uraemia of the idiopathic type or that due to lupus erythematosus. For miscellaneous conditions, it is indicated for tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy, and trichinosis with neurological or myocardial involvement. For intra-articular or soft tissue administration, DEPO-NISOLONE is indicated as adjunctive therapy for short-term administration in synovitis of osteoarthritis, epicondylitis, rheumatoid arthritis, acute non-specific tenosynovitis, acute and subacute bursitis, post-traumatic osteoarthritis, and acute gouty arthritis. For intralesional administration, DEPO-NISOLONE is indicated for keloids, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata, and localised hypertrophic, infiltrated inflammatory lesions of lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis).

Dosing overview

For intra-articular administration in rheumatoid and osteoarthritis, the dose depends on the size of the joint and varies with severity. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks. For large joints (knees, ankles, shoulders) the dose range is 20 to 80 mg; for medium joints (elbows, wrists) 10 to 40 mg; and for small joints (metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular) 4 to 10 mg. For treatment of tendinous or bursal structures, the dose ranges from 4 mg to 30 mg and varies with the condition being treated. For intralesional injection in dermatological conditions, 20 mg to 60 mg is injected into the lesion, with doses ranging from 20 mg to 40 mg by repeated local injections for large lesions. For systemic effect via intramuscular administration, the dosage will vary with the condition being treated. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection. Dosage must be individualised according to the severity of the disease and response of the patient. In patients with adrenogenital syndrome, a single intramuscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 mg to 120 mg.

Key safety warnings

Infections with any pathogen, including viral, bacterial, fungal, protozoan or helminthic organisms, may be associated with use of corticosteroids alone or in combination with other immunosuppressive agents. Corticosteroids can reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, mask some signs of infection, and make it more difficult to locate the source of infections. Corticosteroid-associated infections may be mild, but can be severe and at times fatal, with the rate of occurrence of infectious complications increasing with higher doses. Pharmacologic doses administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression. Acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly. Drug-induced secondary adrenocortical insufficiency may be minimised by gradual reduction of dosage, which may persist for months after discontinuation of therapy; therefore, hormone therapy should be reinstituted in any situation of stress occurring during that period. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may be aggravated. Potentially severe psychiatric adverse reactions may occur with systemic steroids, with symptoms typically emerging within a few days or weeks of starting treatment, though most reactions recover after either dose reduction or withdrawal. Corticosteroids, including methylprednisolone, can increase blood glucose, worsen pre-existing diabetes, and predispose those on long-term corticosteroid therapy to diabetes mellitus. Prolonged use of corticosteroids may produce posterior subcapsular cataracts and nuclear cataracts (particularly in children), exophthalmos or increased intraocular pressure which may result in glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Contraindications

DEPO-NISOLONE is contraindicated in systemic fungal infections, known hypersensitivity to methylprednisolone or any component of the formulation, intravenous, intrathecal, extradural, epidural or any unspecified route of administration, and administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.

PBS listing

DEPO-NISOLONE injection containing methylprednisolone acetate 40 mg in 1 mL is listed on the PBS with 2 items. The listing is restricted and the ex-manufacturer price is A$13.62.

Regulatory history

DEPO-NISOLONE (methylprednisolone acetate 40 mg/1 mL injection vial) was first registered on the ARTG on 14 April 1997.