ML20057A848

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Transmits State Agreements Program Info (SP-93-111)
ML20057A848
Person / Time
Issue date: 08/17/1993
From: Surmeier J
NRC OFFICE OF STATE PROGRAMS (OSP)
To:
GENERAL
References
NUDOCS 9309160040
Download: ML20057A848 (11)
v • d • e


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E UNITED STATES 7;(gh-NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 @ 01 August 17, 1993 ALL AGREEMENT STATES i

TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-93-111)

Your attention is invited to the attached correspondence which contains:

INCIDENT AND EVENT INFORMATION.......

^

PROGRAM MANAGEMENT INFORMATION.......

TRAINING COURSE INFORMATION..........

i TECHNICAL INFORMATION................XX - METASTRON OTHER INFORMATION....................

Supplementary information:

Enclosed are several documents I

related to the new therapy radiopharmaceutical, Metastron, manufactured by Amersham, Inc.

Please note that this product has been licensed by the Illinois Department of Nuclear Safety for i

distribution to persons licensed pursuant to 32 Illinois Administrative Code 330.260 (a) and Part 335 Subpart F.335.5010 or under equivalent licenses (10 CFR Part 35.300) of the NRC or an Agreement State.

We hope this information will be informative and helpful to your program.

If you have further questions regarding this correspondence, please contact the individual named below.

POINT OF CONTACT:

Jim Myers j

TELEPHONE:

(301) 504-2328 FAX (301) 504-3502

}

John J.

Surmeier, Acting Assistant Director for State Agreements Program i

Office of State Programs 1

Enclosures:

j As stated 9309160040 930817 PDR STPRC ESGGEN PDR J

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July 1,1993 d

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Dear 2~:

i The Illinois Department of Nuclear Safety has issued an amendment :o our Medi-Physics License IL-01109-01 permitting the distribution of Metastron (Strontium-89 Chloride) to specific licensees.

Considerable interest has already been expressed in the product which has been cleared for marketing by FDA for palliation of pain in patients with metastatic bone cancer. I i

am sending you this information since I believe you will be receiving inquiries from some l

of your licensees.

i I am enclosing a copy of the package insert and patient information sheet that accompanies each vial of the product.

Please call me (708-593-6300, extension 379) or the Division of Radioactive Materials, l

Illinois Department of Nuclear Safety (217-785-9947) should you have any questions concerning the nuclear licensing of this product. We will be pleased to assist you.

l Sincerely, I

i Bryan W. Baker, Ph.D.

Corporate Manager i

Nuclear Licensing and Industrial Liaison BWB/jc Enclosures

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. corn-oos.reursoor Po2 ENCLOSURE 1 i

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DEPARTMENT OF HEALTH A HUMAN SERVICES Ape Hzean servlee 4

8 005 and or g Adm;nistsst;cm i

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Roc =.we vD 20an l

v NDA 20-134 JJN I 81993 l

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i Ma4i-Phyuics, Inc.

.2636 South Clearbrook Drive Arlington Heights, Illinois 60005 l

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Attention:

John H. Waterman Vice President i

Regulatory Affairs and Quality Assurance

Dear Mr. Waterman:

Reference is made to your new drug application dated i

November 30, 1990, submitted under section 505(b) of the Federal.

Food, Drug, and Cosmetic Act for Metastron (Strontium Er-69 Injection) and to ycur resubmissions of the application dated l

July 26, 1991, and September 28, 1992.

i We have completed our review of this application as amended including the revised draft labeling dated June 15, 1993.

We have concluded that adequate information has been presented to demonstrate that'Metastron (Strontiun Sr-89' Injection) is safe e.nd effective for usa as recommended in the revised labeling.

Accordingly, the application is approved, effective on the date of this letter.

i Please submit 12 copics of the final printed labeling '(FPL) identical to the revised draft labeling, dated June 15, 1993, ac soon as it is available.

Seven of the copies should be individually mounted on heavy weight paper or similar material.

The submission should be designated for administrative purposes as "FpL for Approved NDA 20-134."

Approval of the submission by FDA is not required before the Labeling is used.

Marketing the product with FPL that is not identical to the revised draft labeling may render the product misbranded and an unapproved new drug.

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2e. es o s s s o-P ><

-coom-oor reursoor roa P

Page 2 NDA 20-134 Please submit, in triplicato, theadvertisingcohythatyou intend to.use in your proposed introductory pronotional and/or advertising campaign.

One copy should be sent to the Division of Medical Imaging, surgical and Dental Drug Products, and the second and third copies should be sent to the Division of Drug Marketing, Advertising, and Communications, HFD-240,' 5600 Fishers Lane, Rockville, Maryland 20857.

All proposed materials shcald be in draft or mock-up form, not final print.. Also, please do not use form FDA-2253 for this submission; that form is for routine use, not for proposed natarials.

We remind that you must cor. ply with the requiremente set forth under 21 CFR 314.80 and 314.81 for an approved NDA.

If you have any questions regarding this communication, please contact Ms. Susan Lange, Consumer Safety Officer, at (301) 443-5818.

Sincerely yours,

%6,, S h h 46 Paula Botstein, M.D.

Acting Director Division of Medical Imaging, Surgical and Dental Drug Products and Deputy Director offica of Drug Evaluation I Center for Drug Evaluation and Research 6

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8 pniw' h. 4rr ary plArN. as ad und h> tmhoshcrapy. on mlix an.1 plattln as alpmet to tMothesary. Un ters'nrett omfo9tse over tone-ttivt W pin wtwe and atmigeuc sotre tai rens CON TR AINDiC AllOM Memthe P%Trewnent Months %t lierrwau Nov.e know n t

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diwase iohhrstion is nit trawm*wmled unlew tbc p4cn

$ldl I1Cett* fat pl the lifdffli *nl l1sttuf tph4 ih fwh Itaine Al eJdt 4151I.. trffitinCrit tiULTr%% dCNfwd 3% 8 fytItSt' tat'fl 6 W4 564 y44 4 4.'$

t IH 3 pli: crit'5 l*am sL'Ote %'11himt any irieff 3*.c tot attal-ggy gq, gg g g,py g, g psy, g, ygtpp g 7, gnMnt% t*uirily 1% to fic t%prChl'd I,tlleau my the ad'*terSp4-grue meAe mest nebemt noy worterrentary rain 4hefs-tratrim of Metastete. putnularly wh.te bhwi(elk al py at the m&M site. esis miwr frt*ptefit atrweg patients De member of pistents St.twihot at cash uvt as treat g I.adets The estent of tensity R 4an44 ft a rer nn-swetrd in Mda*.tn m th m to g4atd**.

tr$cnt unctie who were pam fety as the sn&t site arid memled that ik Wi.entT penpher,tl Maid cell tu.ms br teipeired twi analgcuts um esmwenlis h,gher in tfe ti,,,nmited a trast eme om a4ber *ed 1) peas:Is.

I Tath 3 tentpers tte number and pertemage of.patienn Meisstnm pwp.

p!aselets will be de prued by'aNmt. tin es*w.tred io i

tirated woh Mdast+on es t+techo as an a<l um t to radn*

t h n4w d el p*e.k p'n-therapy alw were p.em tire methout analgeuc at the New pam sites were leu tregornt m paherin ttwed m Wo in* min lod, ggg mtcts a!< da en.

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,gy gg in amd ter thmcal tnal. pa.n triref was greater in a trils are stulaff) depenwd to 3 sarying esttwo tiepired i

gnep $4 p.tiie:ms tren'ed with Moastnm menosmi with to pre-miemmutatum lorft Uvreaher errtwm as rues s

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a grsmp treated m ath neu radusadise 5tnetium Itt.

slowly. typically remhmg pre admmestia'*** loch us riumths aher treatitwnt tmiew the p orent s dwa4e or INI.1!CAf TONS ANI) UW;il adtlitumaltheraps mienenn I

Metaunm (Stnmemm R9 Chhnic Inn etumi a imht ateti la conudenng npe,4 a.Inu intrunem of Metastnwn. the for the rehrf of twee pam m panems woh geful skric-pg,gng 3 N.,umot,,ng na.e to the eronal due. rier-bl enetsuaw s

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\\rrifwsme of dv urid patwnt e&ntifwatum ni twers-Sary prsor to anheurnntralism becaint Mciasmm dehvers a triatnrly high av of r.s.hoat twily Mesasitue muy umw trial }u m when udnurnsected to a I

picptwrif munun, 'Itserr arc Tu inlequaw whd mell-suh-3 Imhed Mudecs in pregnant umwn. If tins dong n uwd durmy pergmirw). or if ife p.alent brumr. gwernan

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while vnenmp thn drug. IPw patiens stumld te appn. sed of the potential hazard to the letsn. Konwn of childtrar-t l

mg puem:al nhould te adowd an amd t=umung ptep-l nant l

PRI C AtJTIONS I

ucusmo n w nuncaird for uw m nawmu nh inn i

n.g nwniurig txwr Met.tserm shou d be swd wnh t au-in* m parents unh p!.stekt. counts briew rioJRO arul I

m hete tel! courus bek= 2.4f ML Radnpharmarrute.als should on'y tw u,cd by physi, ciata win)are trualafeed t'y traarung and esperwnee m ttw sale uw and landlmp of radumudules eind utuu expe.

l nemt and trainm; have been appmvis! by she appropro ate ytwernnwnl nyency authorurd to hrense the uw of i

rashonudades Mctuunm. hie other radamine druFs. mint be havidied u nh (are arai aggwopraaie sate 3 p,casurri taken in mmi-mire reihalum to thriscal pt ruivirict.

y In stem of the delayed ontt of pain frhrf, typacal!y 710

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20 dm nwt injectum. admimuratum 44 Met.wsnin h, Pregaunty Catepwy D See)Vyrmgpetwm.

40 #)uC Ag bnfy weight ntay te used.

i patients with wty dwet life esperiancy is not reown-i

,,,,,,g NUR$1NG Mon ti.R5 Repated admmiuranims of Metavnin *.hmid be tmsed

. t em an tmhvidual patierit's tr*sionse to ibevarv. siervem 4

A okinm f,ke ftmbmg sematism nas Fren observed in M anw Senmnum ne u as a causm anah 4 secretum t,4 umptoms, et.nuhdopc status. ami are grNetaH) twit

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pntwnts toilewmg a rap!Orw than 3n second injecluin)

SinmtmasE Chbwide imo homan smW is hken ti is Ntemmenfd at iriters ab cd ten than 00 slavs, I

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admimutsum enmemW Aat nunmg be descoarmted by pubers i

ahmt to receive immenim Smmnum 139 Chhw*le. It is 1bc puent ene skuld be neawed by a sumtble L

S uial perausamt, such as unnary aseheseniatn.m.

en knnun whether this drug is escreted 6n human mdk.

radumnisov tabbraine $3eem mimediately pvw to

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t should be taken h4lowmr admemstratum to patients admimstralion l

who ser ismelincut to niinimire the nsk of rmhiw.the ANC N RADI A110N DO51Mr.TRY f

cimtammsum of cl whing bed linen and the patient's safety and effecnvenew 6n children belon ibe age of 14 etniemmett years hase tet been estabh=hed Dr estimmed rahati<m d. se ihat would be dchsered I

CA RCINOGl:.Nf 315. MUTAGl.NI Sit m one Anytpsp pgAc3 g>N3 pk innam Micaw M l

37 W4 I "4 I "I 5'".'"Ihta are taken fnmi the ICRP iMPAIRMI.NTOf II.RilLITY

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adult as pren in TaNe 4 I

A smpic caw e4 fatal aclawenua fellom mg leukopems Data inen a rep 1itne ame animal simfy suggests that 3,,yp ned dinng tienn!inA Mmt are reactim P"I'!K#"m "R*halion the to hnernes innn Sinmtitem It9 Chhwide is e pi*entint c arrmogen ihnt?-

if mamiw tositety can be numaged by conventamal M*b'phannuuncah" -fCRP #33. Mt 18. No. 1 -4, t'irre of 441 ta% mkcted with Stmntiitm 89 (Mwnic m Page 171. perF"*m Pre". 39M8-

mens, ten enner9tne em nttbly Ames tf enher 2M) ev 350 pCvkg dcrchiped malignet twme tumiws after a A smaH mmter 54 ptienti have reported a tranwnt TaNe 4. Sin num M Dimnetry j

leency perwl of nerensimately 9 num9n No tronlasia mucase in hee ram at 36 to 72 hmrn afwr injectum O

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f was observed in the control ammak Tr. aimers wah Tins is usually nuid ami setf bmiting amt runtrotiable ihme 59tiace 170 610 i

Sinmemm R9 Chlortile should be restncted to panents wifh analpews. A Smide pMernt reented ctuus amliever Red thee Manow 11 0 40.7 t

with weH dwumented metavatic hme diwase.

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METASTRON'

~

(STRONT!UM-89 CHLORIDEINJECTION)

Information for Patients (continued)

What precautions should I take?

The effects of Metastron are confined within your own hx!y. Other people will not be hamaed through hxlily contact with you.

During the fint week after injection, Metastron will be present in your bkxxl and urine. It is therefore important that you should follow the conunon sense precautions listed below for one week.

Where a nonnal toilet is available it shouki be used in preference to a urinal. The toilet should be flushed twice.

Wipe up any spilled urine with a tissue and flush it away.

Ensure that you alway s wash your hands after using the toilet.

Immediately wash any linen or clothes which become stained with urine or bhxxl. Wash them sepamtely from other

+

clothes, and rinse thoroughly.

If you use any urine collection device, take advice on its use from your doctor.

If you should cut y ourself, wash away any spilled blood.

What happens if my pain returns?

In many people w ho receive Metastron, the effect lasts for several months. If pain returns, you should consult your doctor.

The doctor may give you another Metastron injection if this is the most appropriate treatment.

Further Information t

Metastron may only be prescribed and administered by a qualified physician. Your doctor has further infonnation about your treatment and you should not hesitate to ask if you have any questions or concerns.

i Medi-Physics, Inc.

2636 S. Clearbmok Drive i

Arlington Heights, IL 6(XX)5 i

FAmersham HEALTHCARE i

4s.m x -

)

J

MET 4STR0nr

[STROGGM89 CHLORIDEINECTION)

Information for Patients What is Metastron?

For many years doctors have used certain types of radiation to relieve the pain experienced by people like yourself.

Metastron is a new development in this type of treatment. Metastron (Strontium-89 Chloride Injection) contains small 1

amounts of a specially selected form of radioactive strontium, chosen because almost all ofits radiation is given to the area i

where it is absorbed. This allows it to deliver therapy precisely where it is needed.

1 Why has Metastron been prescribed for me?

For many people, Metastron is more appropriate than other types of therapy. It has been prescribed for you as it seems like-ly that it will be the most suitable treatment in your case.

What efTect will Metastrem have?

At first you will feel no effect at all. You may even feel a slight increase in pain for two or three days beginning two or three days after injection This is quite normal, and your doctor may suggest that you temporarily increase your dose of pain killers until the pain is under control.

After about one to two weeks, sometimes a little longer, you should Segin to feel the pain diminish. This reduction in pain should continue and the efTect should then last for several months.

Are there any side efTects?

None that you will normally notice. You can eat and drink nomially and there is no need to avoid alcohol or caffeine unless you have already been advised to do so. There may be a slight fall in the number of cells in your blood and your doctor will want to ca Ty out periodic, routine blood tests. If you have any concerns you should of course talk with your doctor.

Should I stop taking pain killing drugs?

Your doctor may advise you to continue taking your pain killing medicine until Metastron begins to become effectix e. You may then be advised to reduce the dose of your pain medications gradually. Your doctor may want to continue reducing the dose and eventually you may not need pain killers at all. If you have any doubts, consult your doctor.

What about other treatments?

Your doctor will advise you about other treatments that are required. You may have been receiving hormone injections or tablets and your doctor may wish you to continue with these.

What activities can I undertake?

The injection wi!! not precent you from doing anything that you were already doing. As Metastron begins to relieve the pain, you may find that you can tackle activities that were previously too difficult or too painful. Usually there is no prob-lem with this, but be careful not to overda it! If you are in any doubt, seek your doctor's advice.

l Who should I tell ihat I have received Metastron?

You should tell any health practitioner who is giving you rnedical treatment that you have received Metastron, and show them this leaflet.

(continued on back)

~

6 d

GUIDELINES FOR THE CALIBRATION OF METASTRONS (Strontium-89 Chloride Injection)

When supplied, Metastmn* has a radioactive concentration of 37 MBq/mL,1 mci /mL at 0600 CST on its calibration date which is stated on the shipping vial label. The label also states the total activity (148 MBq,4 mci) in the vial on the calibration date and the volume of solution (4 mL) in the vial. Both the radioactive concentration and the activity are determined by liquid scintillation techn! ques traceable to the National Institute of Standards and Technology (NIST). This traceability has been established by both Amersham and NIST performing assays on the same Sr-89 sample and achieving agreement to within 1.5%

Upon receipt of Metastron consult the decay chart in the package insert (see Table I below) and determine the total activity in the vial. (For example,if the calibration date is February 24th then the total activity at 0600 CST on Februaq 14th will be 1.? 5 x 148 MBq,i.e.170.2 MBq, [1.15 x 4 mci, i.e. 4.60 mci] ). Place the vial in the dose calibrator and adjust the potentiometer setting until the electrometer reads the same activity as you just calculated.

This potentiometer setting is then the Sr-89 setting for the particular dose calibrator being used. Make a record of the setting. Please note that different dose calibrators may have different Sr-89 settings and that the above procedure should be repeated for each individual dose calibrator used to measure Sr-89. Additionally,it may be found that a potentiometer setting giving the calculated activity directly cannot be found and that even on the maximum potentiometer setting the indicated activity is much lower than expected. This is because the signal p:oduced in the dose calibrator is relatively small and cannot be converted into the normsl mci activity range. Amersham Healthcare, for example, has found that on certain dose calibrators, using a potentiometer setting of around 600, a calibration factor of 100 has to be introduced in order to get the correct activity. In these cases the activity indicated on the dose calibrator read-out has to be multiplied by a factor of 100 in order to give the correct mci activity, thus for a 4 mci activity the read-out would indicate 40 uCi.

An identical procedure may be followed with the Metastron in a syringe. In this case the radioactive concentration (mci /mL) should first be determined from the decay chart in the i

package insert. (For example, if the calibration date is Februaq 24th then the radioactive concentration at 0600 CST on February 14th will be 1.15 x 37 MBq/mL,i.e. 42.55 MBq/mL,

[1.15 x 1 mci /mL,i.e.1.15 mci /mL].) This concentration should then be multiplied by the volume of Metastron drawn into the syringe to give the total activity in the syringe. The l

syringe is then placed in the dose calibrator and the same procedure as that outlined above

!l for the shipping vial is followed to establish a 'Sr-89 syringe" setting. Please note the setting for the syringe is likely to be different from the setting for the shipping vial. Additionally, the setting for one type of syringe may be different from the setting for a difTerent type of i

syringe and it is advised, therefore, that a settingis established for each type / size of syringe used for Metastron*.

l O

Alternatively, the following method can be used to determine the activity in the syringe:

aner determining the total activity in the shipping vial draw the required dose into the syringe. Reassay the shipping vial to determine the activity remaining in the vial and then the activity in the syringe is given by subtracting this activity from the original actisity in the shipping sial.

For subsequent vials / syringes of Metastron dial in the appropriate Sr-89 potentiometer setting as previously established by the methods outlined above. Place the vial / syringe in the dose calibrator and measure the activity. Consult the label and the decay chart in the package insert and determine the expected activity in the vial / syringe to confirm agreement.

Table 1: Decay of Strontium-89 Day

  • Factor Day
  • Factor

-24 1.39

+6 0.92

-22 1.35

+8 0.90

-20 1.32

+10 0.87

-18 1.28

+ 12 0.85 3

-16 1.25

+ 14 0.83

-14 1.21

+16 0.80

-12 1.18

+ 18 0.78

-10 1.15

+20 0.76

-8 1.12

+22 0.74

-6 1.09

+24 0.72

-4 1.06

+26 0.70

-2 1.03

+28 0.68 0 = calibration 1.00

  • Days before (-) or after (+) the calibration date stated on the vial.

If further information is required concerning the calibration of Metastron please call 1-800-i 554-0157.

{ Please note: the above information is provided for guidance only. It does not supersede NRC or individual Agreement State requirements for the calibration of therapeutic radiopharmaceuticals. Indisidual establishments should confirm that the calibration procedures adopted conform to the appropriate NRC/ State regulations. }

i

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