よむ、つかう、まなぶ。
資料5-2 Ⅲ-マル1-73 リツキシマブ[1004KB] (38 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000198856_00046.html |
| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議(第68回 5/25)《厚生労働省》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
要望番号;III➀-73
evaluation. There may be situations where it does not seem possible to
proceed with R-COPADM1 at D8, then a second course of COP should be
considered:
•
the patient is too unstable to receive R-COPADM1, i.e. patients with
renal failure, creatinine clearance < 60 ml/min/1.73m2, septicaemia or
other sepsis or grade 3/4 organ toxicity, then a second course of COP
should be considered.
•
In the case of significant effusion at diagnosis (with a risk of MTX
accumulation):
- If the effusion is small at D7 assessment, ignore and continue
R-COPADM1.
- If significant effusions but adequate overall response then give next
course with MTX at day 5 instead of day 1 or consider to give a
second course COP.
- If significant effusions and no response (< 20% reduction), then move
to Group C1 and give next course with MTX at day 5 instead of day
1 (as long as effusions small).
•
elevation of transaminases, sometimes with an increase in liver size,
can be seen after COP and is probably due to a combination of
corticosteroids and poor nutrition status (where this was present at
outset). In the case of transaminases > 10 × ULN it is preferable to
wait 48 hours and proceed to R-COPADM1 if transaminases decrease.
If not, give a second course of COP.
In any case when R-COPADM1 has to be postponed, Rituximab will not be
given with R-COPADM1, but at the planned time, ie at D6 and D8 of 1st
COP, if the clinical situation is controlled.
7.2. Group B, high risk: Induction: R-COPADM course n°1 and course
n°2
R-COPADM1 starts on D8 of COP (can delay for up to 3 days if ongoing
metabolic/other problems).
Note: Control renal function before administrating methotrexate. If GFR is
< 60 ml/min/1.73m2 delay methotrexate until GFR > 60 ml/min/1.73m2.
Rituximab 375 mg/m2 on D-2 (= D6 COP) and on D1, before starting
chemotherapy.
Premedicate with paracetamol and chlorpheniramine as per BNFC dosing
and administer as per local practice.
34
evaluation. There may be situations where it does not seem possible to
proceed with R-COPADM1 at D8, then a second course of COP should be
considered:
•
the patient is too unstable to receive R-COPADM1, i.e. patients with
renal failure, creatinine clearance < 60 ml/min/1.73m2, septicaemia or
other sepsis or grade 3/4 organ toxicity, then a second course of COP
should be considered.
•
In the case of significant effusion at diagnosis (with a risk of MTX
accumulation):
- If the effusion is small at D7 assessment, ignore and continue
R-COPADM1.
- If significant effusions but adequate overall response then give next
course with MTX at day 5 instead of day 1 or consider to give a
second course COP.
- If significant effusions and no response (< 20% reduction), then move
to Group C1 and give next course with MTX at day 5 instead of day
1 (as long as effusions small).
•
elevation of transaminases, sometimes with an increase in liver size,
can be seen after COP and is probably due to a combination of
corticosteroids and poor nutrition status (where this was present at
outset). In the case of transaminases > 10 × ULN it is preferable to
wait 48 hours and proceed to R-COPADM1 if transaminases decrease.
If not, give a second course of COP.
In any case when R-COPADM1 has to be postponed, Rituximab will not be
given with R-COPADM1, but at the planned time, ie at D6 and D8 of 1st
COP, if the clinical situation is controlled.
7.2. Group B, high risk: Induction: R-COPADM course n°1 and course
n°2
R-COPADM1 starts on D8 of COP (can delay for up to 3 days if ongoing
metabolic/other problems).
Note: Control renal function before administrating methotrexate. If GFR is
< 60 ml/min/1.73m2 delay methotrexate until GFR > 60 ml/min/1.73m2.
Rituximab 375 mg/m2 on D-2 (= D6 COP) and on D1, before starting
chemotherapy.
Premedicate with paracetamol and chlorpheniramine as per BNFC dosing
and administer as per local practice.
34