Product news (17 October 2009)
Solution for injection in prefilled syringe.
Tumour necrosis factor alpha inhibitor.
In combination with methotrexate for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs has been inadequate.
Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
The starting dose of Cimzia is 400mg (as two injections of 200mg each on one day) at weeks zero, two and four, followed by a maintenance dose of 200mg every two weeks. Methotrexate should be continued during treatment with Cimzia where appropriate.
Administration is by subcutaneous injection only and suitable sites include the thigh and abdomen. After training in injection technique, patients may self-inject.
Active tuberculosis or other severe infections such as sepsis or opportunistic infections, and moderate to severe heart failure.
Treatment with Cimzia must not be initiated in patients with a clinically important active infection and patients who develop an infection during treatment should be monitored closely.
Patients must be monitored closely for signs and symptoms of infection including tuberculosis before, during and for five months after treatment with Cimzia.
Patients should be advised to seek medical advice if signs and symptoms suggestive of tuberculosis infection occur during or after therapy with Cimzia, and therapy must be discontinued if active TB is diagnosed.
Carriers of the hepatitis B virus should be monitored for signs of active infection throughout therapy and for five months after treatment is stopped.
If patients develop hepatitis B virus infection, Cimzia should be discontinued.
Caution should be exercised in patients with chronic obstructive pulmonary disease and those with increased risk of malignancy due to heavy smoking or a history of malignancy.
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor).
Discontinuation of Cimzia should be considered in those with significant haematological abnormalities.
If a patient develops lupus-like syndrome or new or worsening symptoms of congestive heart failure, treatment must be discontinued.
Live vaccines, attenuated vaccines, anakinra and abatacept should not be administered concurrently with Cimzia.
Cimzia is not recommended for use in those under 18 years of age.
Women of child bearing age should use adequate contraception and continue its use for at least five months after the last Cimzia administration.
A decision on whether to continue breastfeeding or Cimzia should be made taking into account the benefit of breastfeeding to the child and benefit of Cimzia therapy to the woman.
Common (=1/100 to <1/10) bacterial infections, viral infections, eosinophillic disorders, leucopenia, headaches, sensory abnormalities, hypertension, hepatitis, rash, pain, pruritis, pyrexia, asthaenia and reactions at injection sites.
2 x 1ml syringe, £715
UCB Pharma, 208 Bath Road, Slough SL1 3WE (tel 01753 534655).
Dipeptidyl peptidase 4 inhibitor.
Adult patients with type 2 diabetes to improve glycaemic control:
- in combination with metformin when metformin alone, with diet and exercise, does not provide adequate glycaemic control
- in combination with a sulphonylurea when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate
- in combination with a thiazolidinedione when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate
5mg once daily as add-on combination therapy with metformin, a thiazolidinedione or a sulphonylurea. If a dose is missed, it should be taken as soon as the patient remembers.
A double dose should not be taken on the same day.
Onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Onglyza is not recommended for children or adolescents, patients with moderate to severe renal impairment or severe hepatic impairment.
Caution should be exercised when treating patients aged 75 years and over.
A lower dose of sulphonylurea may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza.
Monitoring for skin disorders such as blistering, ulceration or rash, is recommended.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Onglyza.
Onglyza should not be used during pregnancy unless clearly necessary. Either breastfeeding or therapy should be discontinued based on the risk-benefit ratio.
In patients receiving Onglyza monotherapy, upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, headache and vomiting are listed as common (=1/100 to <1/10) side effects.
In patients receiving Onglyza with metformin, upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, nasopharyngitis, headache and vomiting are listed as common side effects.
In patients receiving Onglyza with a sulphonylurea, hypoglycaemia is listed as a very common (=1/10) side effect upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, headache and vomiting are listed as common side effects.
In patients receiving Onglyza with a thiazolidinedione, upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, headache, vomiting and peripheral oedema are listed as common side effects.
28 x 5mg, £31.60
Bristol-Myers Squibb, Uxbridge Business Park, Sanderson road, Uxbridge, Middlesex UB8 1DH (tel 01895 523000).
Concentrate for solution for infusion.
In combination with methotrexate, RoActemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, previous therapy with one or more disease modifying antirheumatic drugs or tumour necrosis factor antagonists.
In these patients, RoActemra can be given as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate.
The recommended dose is 8mg/kg, but no lower than 480mg, given once every four weeks.
RoActemra should be administered as an intravenous infusion over one hour.
Active, severe infections.
Renal function should monitored in those with moderate to severe renal impairment.
RoActemra should not be initiated in patients with active infections.
Administration should be interrupted if a patient develops a serious infection, until the infection is controlled.
Patients should be screened for tuberculosis infection before starting RoActemra therapy.
RoActemra should be used with caution in patients with a previous history of intestinal ulceration or diverticulitis, active hepatic disease or impairment, and in patients with a low neutrophil or platelet count.
Live and live attenuated vaccines should not be given concurrently with RoActemra.
RoActemra contains 1.17mmol (26.55mg) sodium per maximum dose of 1,200mg, which should be taken into account for patients on a controlled sodium diet.
Patients taking medicines which are individually adjusted and are metabolised via CYP450 3A4, 1A2, 2C9 or 2C19 should be monitored as doses of these medicines may need to be increased to maintain therapeutic effect.
The effect of RoActemra on CYP450 may persist for several weeks after stopping therapy because of RoActemra’s long elimination half-life.
RoActemra should not be used during pregnancy unless clearly necessary. A decision on whether to continue breastfeeding or RoActemra should be made taking into account the benefit of breastfeeding to the child and of RoActemra therapy to the woman.
Very common (=1/10) upper respiratory tract infections.
Common (=1/100 to <1/10) cellulitis, pneumonia, oral herpes simplex, herpes zoster, mouth ulceration, gastritis, rash, pruritus, headache, dizziness, increased hepatic transaminases, hypertension, leucopenia, neutropenia, hypercholesterolaemia and conjunctivitis.
1 x 80mg, £102.40
1 x 200mg, £256
1 x 400mg, £512
Roche Products, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire AL7 1TW (tel 0800 3281629).
Citation: The Pharmaceutical Journal URI: 10982249