1 Dosing Considerations Cutaquig® is for subcutaneous administration only. Do not administer intravenously or intramuscularly. Cutaquig® can be administered at regular intervals from daily up to every two weeks (biweekly). Individualize the dose based on the patient’s IgG trough concentration and clinical response.
Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed (see Dose Adjustment). Potential complications can often be avoided by: - Initially injecting the product slowly - Ensuring that patients are carefully monitored for any symptoms throughout the infusion period.
In particular, patients naive to human normal immunoglobulin, patients switched from an alternative immunoglobulin product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
All other patients should be observed for at least 20 minutes after administration. Serious Warnings and Precautions • The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering to the patient (see 7 WARNINGS AND PRECAUTIONS – General).
• Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
In case of shock, standard medical treatment should be administered. • There is clinical evidence of an association between the administration of immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis.
Therefore, caution should be exercised when prescribing and administering immunoglobulins. • Risk factors for thromboembolic events include: advanced age, use of estrogens, in- dwelling central vascular catheters, history of vascular disease or thrombotic episodes, acquired or inherited hypercoagulable states, prolonged periods of immobilization, severe hypovolemia, diseases which increase blood viscosity and cardiovascular risk factors (including obesity, hypertension, diabetes mellitus, history of atherosclerosis and/or impaired cardiac output).
• Thrombosis may occur even in the absence of known risk factors (see 7 WARNINGS AND PRECAUTIONS – Thromboembolism). 2g/kg body weight (BW) administered subcutaneously. Cutaquig® can be administered at regular intervals from daily up to every other week.
, for 3 times per week dosing, divide weekly dose by 3). - For every other week dosing, multiply the calculated weekly cutaquig® dose by 2. To convert a cutaquig® dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 6.
2 to 3 mL/kg body weight) divided over several days. Starting treatment with cutaquig®: - For weekly or more frequent dosing, start treatment with cutaquig® 1 week after the patient’s last IVIG infusion or SCIG infusion. - For every other week dosing, start treatment 1 or 2 weeks after the last IVIG infusion or 1 week after the last weekly SCIG infusion.
17 g per 1 mL).
Dose for patients switching to cutaquig® from IVIG replacement therapy:
To calculate the initial weekly dose of cutaquig®, convert the recommended monthly IVIG dose into a equivalent weekly dose and increase it using a dose adjustment factor. 30. , for 3 times per week dosing, divide weekly dose by 3). - For every other week dosing, multiply the calculated weekly cutaquig® dose by 2.
Dose for patients switching to cutaquig® from another SCIG replacement therapy: - For patients already on SCIG treatment the dosing recommendation is to start with an initial cutaquig® dose that is equal to the previous SCIG dose. - The previous weekly SCIG dose should be maintained for weekly dosing.
, for 3 times per week dosing, divide weekly dose by 3). - For every other week dosing, multiply the weekly dose by 2. <CUTAQUIG><Immunoglobulin (human) subcutaneous> Page 7 of 39 Dose Adjustment Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level.
However, the patient’s clinical response should be the primary consideration in dose adjustment. Measure the patient’s serum IgG trough level 2-3 months after switching to cutaquig® or after the last cutaquig® dose adjustment, in order to determine if a dose adjustment is necessary.
Calculate the difference between the patient’s target serum IgG trough level (in mg/dL) and the IgG trough level obtained during subcutaneous treatment with cutaquig®. Find this […]